GENESIS REUSABLE RIGID CONTAINER SYSTEM

• K Number: K112535
• Device Name: GENESIS REUSABLE RIGID CONTAINER SYSTEM
• Manufacturer: CAREFUSION 2200, INC.
• Date Cleared: 2012-04-27 ( 239 days)
• Product Code: KCT
• Regulation Number: 880.6850

Intended Use

The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days. Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use. Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container. Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

Device Description

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing.

Predicate Devices

K844652, K983299, K012931

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the physical components and sterilization function of a reusable container system. There is no mention of AI or ML in the text, and the performance studies are related to sterilization efficacy and shelf life, not algorithmic performance.

Therapeutic

No.
This device is designed to sterilize and maintain the sterility of other medical devices, not to provide a therapeutic effect on a patient.

Diagnostic

No.
Explanation: The device is a sterilization container system. It is used to sterilize other medical devices and maintain their sterility, rather than to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as lids, bottoms, filters, tamper evident arrows, data cards, and baskets. These are all hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used to enclose another medical device for sterilization and maintain its sterility. It does not mention analyzing biological samples or providing diagnostic information about a patient's health.
• Device Description: The description focuses on the physical components of a container system for sterilization and storage.
• Performance Studies: The performance studies described relate to the efficacy of sterilization and the maintenance of sterility, not to diagnostic accuracy or the analysis of biological samples.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days. Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use. Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container. Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Test Summary-New Device:
Sterilization Efficacy: Pre-Vacuum Steam; and 100% Ethylene Oxide - Testing demonstrated a 12 log reduction and sterility assurance level (SAL) of 10-6 using biological (BI) overkill method and half-cycle validation.
180 Day Event Related Shelf Life for all Sterilization Modalities - 180 Day Event Related Shelf life studies demonstrated sterility maintenance for all sterilization modalities.
Microbial Challenge - Whole package microbial challenge test exposing a container to a minimum of 1 x10^6 Bacillus atrophaeus colony forming units (CFU) via an aerosol challenge demonstrating 100% negative growth.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K844652, K983299, K012931

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

0

APR 2 7 2012

KIT2535

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510(k) SUMMARY

Following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

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and the comments of the comments of

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Name	CareFusion
Address	1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA
Phone number	847-473-7334
Fax number	847-473-7790
Establishment Registration
Number	1423507
Name of contact person	Kate Fuller
Date prepared	April 12, 2012
NAME OF DEVICE
Trade or proprietary name	Genesis Reusable Rigid Container system
Common or usual name	Sterilization Container
Classification name	Sterilization Wrap Containers, Trays, Cassettes and Other Accessories
Classification panel	80
Regulation	880.6850
Product Code(s)	KCT
Legally marketed
device(s) to which
equivalence is claimed	K844652 - Genesis Sterilization Container
K983299 - Genesis Deep Lid Sterilization Container
K012931 - Genesis STERRAD Sterilization Container
Reason for 510(k)
submission	One filter for all sterilization modalities New container sizes Expand indications for use to include Immediate Use Sterilization Modify parameters for Pre-Vacuum Steam and 100% Ethylene Oxide Replace 88/12 Ethylene Oxide with 100% Ethylene Oxide
Device description	The Genesis Reusable Rigid Container System is an assortment of rigid,
reusable, stackable containers that are used to sterilize other medical devices
and maintain sterility of these devices until used. The container system is
comprised of a lid, bottom, filter, tamper evident arrows, and data cards.
The container system houses baskets of varying depths and organizing.

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| | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO
THE PREDICATE DEVICE | |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | New/Modified Device | Predicate |
| Container | Anodized Aluminum 5000 and
1100 Series; Stainless Steel 300
series | Genesis Container (K844652); Genesis
Deep Lid Container (K983299) Genesis
STERRAD Compatible Container
(K012931) |
| Gasket | Closed Cell Silicone Foam | SAME |
| Filter Material | SMS Polypropylene for all
Modalities | SAME for STERRAD modality;
Non woven Cellulose for Steam and EO |
| Baskets | 304 Stainless; Electropolished | SAME |
| Dividers, Brackets | Aluminum 5000 Series | SAME |
| Clips, Posts, Pins | 300 and 400 Series Stainless | SAME |
| Silicone Bars, Mats | Silicone Elastomer | SAME |
| | PERFORMANCE DATA | |
| | SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE | |
| | Performance Test Summary-New Device | |
| Characteristic | Standard/Test/FDA
Guidance | Results Summary |
| Sterilization Efficacy: Pre-
Vacuum Steam; and 100%
Ethylene Oxide | ST 77 2006 Containment
Devices for Reusable
Medical Device Sterilization | Testing demonstrated a 12 log reduction and
sterility assurance level (SAL) of 10 6 using
biological (BI) overkill method and half-cycle
validation. |
| 180 Day Event Related
Shelf Life for all Sterilization
Modalities | ST 77:2006 Containment
Devices for Reusable
Medical Device Sterilization | 180 Day Event Related Shelf life studies
demonstrated sterility maintenance for all
sterilization modalities. |
| Microbial Challenge | ST.77:2006 Containment
Devices for Reusable
Medical Device Sterilization | Whole package microbial challenge test
exposing a container to a minimum of 1 x10 6
Bacillus atrophaeus colony forming units (CFU)
via an aerosol challenge demonstrating 10 0%
negative growth |

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EQUIVALENCE ANDION OF OF OLINERS .............................................................................................................................................

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AND A CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL AND CLINICAL DATAS OF SYcteds

The results of the non-clinical tests show that the Genesis Reusable Rigid Container System meets or exceeds
The results of the non-clinical test in conventially coulvalent The results of the non-cimical tests show that the Ochools Nouses of the predicate devices.

SERVICE CARDER THE CINTENDED USE OF DEVICE TO FOR SECTION CONSERVENT SERVER SERVEN

Intended Use	The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of-180 days.
	Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.
	Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.
	Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

Sterilization Method	Cycle Parameters	Total System Weight	Applicable Containers/Accessories
Dynamic Air Removal
(Pre-Vacuum) Steam	Exposure Temperature: 270°F
(132°C)	25 lbs.	Solid Bottom Containers;
Perforated Bottom
Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450 mm)
	Pre-Conditioning Pulses: 3
Exposure Time: 4 Minutes
Dry Time Cycle: 30 minutes		Devices or Device
Configurations entailing
conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate
	Minimum Cool Time: 60 minutes
(may vary according to load contents)		Materials: Stainless Steel
Aluminum;
Silicone; Radel
	Stack Height: Maximum 3

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Sterilization Method	Cycle Parameters	Total System Weight	Applicable Containers/Accessories
Dynamic Air Removal
(Pre-Vacuum) Steam

Immediate Use | Exposure Temperature: 270°F (132°C)

Pre-Conditioning Pulses: 3

Exposure Time: 4 Minutes

Stack Height: Maximum 3

Note: Devices must be used
immediately and cannot be stored
for later use. | 25 lbs. | Solid Bottom Containers;
Perforated Bottom
Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm
x 450 mm)
Devices or Device
Configurations entailing
conjoined surfaces which
meet, touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective Plate

Materials: Stainless Steel,
Aluminum;
Silicone; Radel |
| 100% Ethylene Oxide | EO Sterilant Concentration: 100%
EO, 725 mg/L

Pre-conditioning Time: 30 minutes

Temperature: 130°F (55°C)

Exposure Time: 60 minutes

Relative Humidity: 50-80%

Aeration: 8 hours @ 109.4°F (43°C)

No stacking | 15 lbs. | Perforated Bottom
Containers except CD2-
10BDL and DINCD2-8B);
Non Stacking Baskets
Lumen Devices (3.0 mm x
400 mm)
Device or Device
Configurations entailing
conjoined surfaces which
meet, touch or unite;
Silicone Support Bars;
Laparoscopic Racks;

Materials: Stainless Steel,
Aluminum, Silicone, Radel |

Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), Examples of instrument types that are conjoined increases roresps, kerrison rongeurs, specula.
and self retaining retractors, needle holders, ostectores that are commercly ob and self retaining retractors, needle holders, ostections is rollegely of the morely obstructed. These types of devices
Note: Air tight occluded challenges are devices entai Note: Air tight occluded challenges are devices Encaling our association Container System.
have not been validated for use in the Genesis Reusable Sterilization Container Sys :

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	Accessories and Device Challenges by Sterilization Modality and Container Style
Type of Container	Contents/Configuration	Pre-Vacuum Steam	100% Ethylene Oxide
Solid Bottom Container	Non Stacking Baskets	Yes	No
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x
450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400 mm (L)	Yes, maximum 2	No
	Occluded/Mated
Challenge	Yes	No
	Silicone Support Bar	Yes	No
	Silicone Mat	Yes	No
	Laparoscopic Rack	Yes	No
	Optional Protective Plate	Yes	No
	Filter	NST Series	No
	Data Card	MD1-1	No
	Tamper-Evident Arrow	White AS Series	No
	Stack Height	3	No
	Materials	Radel,
Stainless Steel
Aluminum
Silicone	No
	Maximum Total
Container System
Weight	25 lbs.	No
Perforated Bottom
Container	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x
450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400
mm (L)	Yes, maximum 2	Yes, maximum 5
	Occluded/Mated
challenge	Yes	Yes
	Silicone Support Bars	Yes	Yes
	Silicone Mat	Yes	No
Note: The CD2-10BDL
and DINCD2-8B
container models are
not validated for use in
100% Ethylene Oxide
sterilization	Laparoscopic Rack	Yes	Yes
	Optional Protective Plate	Yes	No
	Filter	NST series	NST series
	Data Cards	MD1-1	MD1-1
	Tamper Evident Arrow	White AS Series	Yellow AG Series
	Stack Height	3 max	No stacking
	Materials	Radel
Stainless Steel
Aluminum
Silicone	Radel
Stainless Steel
Aluminum
Silicone
Type of Container	Contents/Configuration	Pre-Vacuum Steam	100% Ethylene Oxide
	Maximum Total Weight	25 lbs.	15 lbs.
STERRAD Compatible
Containers	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x
450mm (L)	Yes, maximum 2	No
	Lumen: 3.0mm (ID) x
400mm (L)	Yes, maximum 2	Yes, maximum 5
	Occluded/Mated
Challenge	Yes	Yes
	Silicone Support Bars	Yes	Yes
	Silicone Mat	Yes	No
	Laparoscopic Rack	Yes	Yes
	Optional Protective Plate	Yes	No
	Filter	NST Series	NST Series
	Data Cards	MD1-1	MD1-1
	Tamper-Evident Arrow	White AS Series	Yellow AG Series
	Stack Height	3 Maximum	No Stacking
	Materials	Radel
Stainless Steel
Aluminum
Silicone	Radel
Stainless Steel
Aluminum
Silicone
	Maximum Total
Container System
Weight	25 lbs.	15 lbs.

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Solid Bottom Containers			Container
Catalog
Code	Description	Container Dimension (in)	Weight (lb.)
CD0-4C	Quarter Length Container	9.5 x 12.4 x 3.8	3.4
CD1-4C	Half Length Container	11.8 x 12.4 x 4.5	4.8
CD1-5C	Half Length Container	11.8 x 12.4 x 5.3	5.0
CD1-6C	Half Length Container	11.8 x 12.4 x 6.1	5.2
CD2-4C	Mid Length Container	19.2 x 12.4 x 4.5	6.4
CD2-5C	Mid Length Container	19.2 x 12.4 x 5.3	6.7
CD2-6C	Mid Length Container	19.2 x 12.4 x 6.1	6.9
CD2-8C	Mid Length Container	19.2 x 12.4 x 7.8	7.3
CD3-4C	Full Length Container	23.1 x 12.4 x 4.5	7.8
CD3-5C	Full Length Container	23.1 x 12.4 x 5.3	7.9
CD3-6C	Full Length Container	23.1 x 12.4 x 6.1	8.2
CD3-7C	Full Length Container	23.1 x 12.4 x 7.0	8.5
CD7-5C	Extra Long Container	25.2 x 12.4 x 5.9	8.5
CD7-6C	Extra Long Container	25.2 x 12.4 x 6.7	8.8
CD7-9C	Extra Long Container	25.2 x 12.4 x 8.4	9.7
CD4-3C	Small Narrow Container	20.8 x 7.3 x 3.9	4.2

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| Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb) |
|-----------------|---------------------------|--------------------------|--------------------------|
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | |
| DINCD1-6C | Half Length Container | 11.6 x 11.4 x 6.1 | |

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| Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb.) |
|-----------------|--------------------------|--------------------------|---------------------------|
| CD0-4B | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4B | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5B | Half Length Container | 11.8 x 12.4 x 5.3 | 5.5 |
| CD1-6B | Half Length Container | 11.8 x 12.4 x 6.1 | 5.7 |
| CD2-4B | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5B | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.1 |
| CD2-6B | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.4 |
| CD2-8B | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.8 |
| CD3-4B | Full Length Container | 23.1 x 12.4 x 4.5 | 8.5 |
| CD3-5B | Full Length Container | 23.1 x 12.4 x 5.3 | 8.8 |
| CD3-6B | Full Length Container | 23.1 x 12.4 x 6.1 | 9.0 |
| CD3-7B | Full Length Container | 23.1 x 12.4 x 7.0 | 9.4 |
| CD7-5B | Extra Long Container | 25.2 x 12.4 x 5.9 | 9.0 |
| CD7-6B | Extra Long Container | 25.2 x 12.4 x 6.7 | 9.4 |
| CD7-9B | Extra Long Container | 25.2 x 12.4 x 8.4 | 10.0 |
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
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| Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb) |
|-----------------|----------------------------|--------------------------|--------------------------|
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container. | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container. | 11.6 x 11.4 x 6.1 | 5.7 |

DINCD1-5B	Half Length DIN Container.	11.6 x 11.4 x 5.4	5.5
DINCD1-6B	Half Length DIN Container	11.6 x 11.4 x 6.1	5.7
STERRAD Style Containers
Catalog Code	Description	Container Dimension (In)	Container Weight (lb.)
CD0-4ST	Quarter Length Container	9.5 x 12.4 x 3.8	3.7
CD1-4ST	Half Length Container	11.8 x 12.4 x 4.5	5.2
CD1-5ST	Half Length Container	11.8 x 12.4 x 5.3	5.4
CD1-6ST	Half Length Container	11.8 x 12.4 x 6.1	5.6
CD2-4ST	Mid Length Container	19.2 x 12.4 x 4.5	6.8
CD2-5ST	Mid Length Container	19.2 x 12.4 x 5.3	7.0
CD2-6ST	Mid Length Container	19.2 x 12.4 x 6.1	7.2
CD2-8ST	Mid Length Container	19.2 x 12.4 x 7.8	7.7
CD3-4ST	Full Length Container	23.1 x 12.4 x 4.5	8.4
CD3-5ST	Full Length Containers	23.1 x 12.4 x 5.3	8.6
CD3-6ST	Full Length Containers	23.1 x 12.4 x 6.1	8.9
CD3-7ST	Full Length Containers	23.1 x 12.4 x 7.0	9.3
CD4-3ST	Small Narrow Shallow Container	20.8 x 7.3 x 3.9	4.2
CD4-5ST	Small Narrow Container	20.8 x 7.3 x 5.2	4.8
CD5-3ST	Large Narrow Shallow Container	28.1 x 11.2 x 5.0	8.9
CD5-61ST	Large Narrow Shallow Container	28.1 x 11.2 x 6.4	9.4
CD0-3ST	Mini Container	10.2 x 7.2 x 3.2	2.6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR 2 7 2012

Ms. Kate Fuller Regulatory Manager CareFusion 2200, Inc. 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K112535

Trade/Device Name: Genesis Reusable Rigid Sterilization Container System and Accessories

Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: April 13, 2012 Received: April 13, 2012

Dear Ms.Fuller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

9

Page 2 - Ms. Fuller

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

1500 Waukegan Road McGaw Park, IL 600085 847-473-7334 tel.

carefusion.com

CareFusion

Indications for Use

510(k) Number:

K112535

Device Name:

Genesis Reusable Rigid Sterilization Container System and Accessories

Indications for Use:

The Genesis Reusable Rigid Sterilization Container System is a device intended to The Genesis Reusable Right Stellization Contraction of the Markhcare
be used to enclose another medical device that is to be sterilized by a healthcare be used to enclose another medical device in edical device and maintains
provider. It allows sterilization of the enclosed medical device and maintains provider. It allows stermization of or a maximum of 180 days.
sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization,
Containers are suitable for dynamic alling and 100% othylene oxide Containers are suitable for dynamis arilization and 100% ethylene oxide
immediate use pre-vacuum steam sterilization and 100% ethylene oxide minnediate use pre-vasualisms and in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to
r and accessory items devices deving sterilization and storage of Reusable baskets and accessory Rems (pins) of the supering sterilization and storage of the container.

Data cards are used to record information regarding a specific sterilization process
. In the card to record information revident while providing a microbial Data cards are used to record information in a microsiding a microbial
load. Filter media allows ingress and egress of sterilant what the container load. Filter media allows ingress and og our sual indication that the contains i barrier. Tamper evident arrows provised prior to use. Each arrow contains a
system has not been inadvertently opened prior as a visual indication th system has not been madvertently opened that serves as a visual indication that
modality-specific external process indication ovelo parameter. Data card modality-specific external process matcator that other corrected. Data cards,
the system has been exposed to a specific sterilization cycle parameter. Data cards, the system has been arrows are single use only.

Prescription Use (Per 21 CFR 801.109)

(please do not write below this line. continue on another page)

Ely L.L. F. Clavin-Will
(Division Sign-Off)

Over the Counter Use

Concurrence of CDRH, Office of Device Evaluation

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 7

510(k) Number:

11

| Sterilization Method | Cycle Parameters | Total System Weight | Applicable
Containers/Accessories |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dynamic Air Removal
(Pre-Vacuum) Steam | Exposure Temperature: 270°F
(132°C)

Pre-Conditioning Pulses: 3

Exposure Time: 4 Minutes

Dry Time Cycle: 30 minutes

Minimum Cool Time: 60 minutes
(may vary according to load contents)

Stack Height: Maximum 3 | 25 lbs. | Solid Bottom
Containers;
Perforated Bottom
Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450 mm)
Devices or Device Configurations
entailing conjoined surfaces which meet,
touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective
Plate
Materials: Stainless
Steel, Aluminum;
Silicone; Radel |
| Dynamic Air Removal
(Pre-Vacuum) Steam

Immediate Use | Exposure Temperature: 270°F
(132°C)

Pre-Conditioning Pulses: 3

Exposure Time: 4 Minutes

Stack Height: Maximum 3

Note: Devices must be used
immediately and cannot be
stored for later use. | 25 lbs. | Solid Bottom
Containers;
Perforated Bottom
Containers;
Stacking Baskets
Non-Stacking Baskets
Lumen Devices (2.68 mm x 450 mm)
Devices or Device Configurations
entailing conjoined surfaces which meet,
touch or unite;
Silicone Support Bars
Silicone Mats
Laparoscopic Racks
Optional Protective
Plate
Materials: Stainless
Steel, Aluminum;
Silicone; Radel |
| Sterilization Method | Cycle Parameters | Total System Weight | Applicable Containers/Accessories |
| 100% Ethylene Oxide | EO Sterilant Concentration:
100% EO, 725 mg/L

Pre-conditioning Time: 30 minutes

Temperature: 130°F (55°C)

Exposure Time: 60 minutes

Relative Humidity: 50-80%

Aeration: 8 hours @ 109.4°F (43°C)

No stacking | 15 lbs. | Perforated Bottom Containers except
CD2-10BDL and
DINCD2-8B);
Non Stacking Baskets
Lumen Devices (3.0 mm x 400 mm)
Device or Device Configurations
entailing conjoined surfaces which meet,
touch or unite;
Silicone Support Bars;
Laparoscopic Racks;

Materials: Stainless Steel, Aluminum,
Silicone, Radel |

ality

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Examples of instrument types that are conjoined include: scissors, forceps, clamps (including double action), Examples of instrument types that are conformed includers, osteotomes/chisels, rongeurs,
hand held and self retaining retractors, needle holders, osteotomes/chisels, rongeur specula.

specula.
Note: Air tight occluded challenges are devices entailing surfaces that are completely obstruction System Note: All tight occided Challenges are devices chiese and the Serilization Container System.
of devices have not been validated for use in the Genesis Reusable Sterilization

Page 3 of 7

13

Accessories and Device Challenges by Sterilization Modality and Container Style

Type of Container	Contents/Configuration	Pre-Vacuum Steam	100% Ethylene Oxide
Solid Bottom Container	Non Stacking Baskets	Yes	No
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x
450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400
mm (L)	Yes, maximum 2	No
	Occluded/Mated
Challenge	Yes	No
	Silicone Support Bar	Yes	No
	Silicone Mat	Yes	No
	Laparoscopic Rack	Yes	No
	Optional Protective Plate	Yes	No
	Filter	NST Series	No
	Data Card	MD1-1	No
	Tamper-Evident Arrow	White AS Series	No
	Stack Height	3	No
	Materials	Radel,
Stainless Steel
Aluminum
Silicone	No
	Maximum Total
Container System
Weight	25 lbs.	No
Perforated Bottom
Container	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x
450mm (L)	Yes, maximum 2	No
	Lumen: 3 mm (ID) x 400
mm (L)	Yes, maximum 2	Yes, maximum 5
	Occluded/Mated
challenge	Yes	Yes
	Silicone Support Bars	Yes	Yes
	Silicone Mat	Yes	No
	Laparoscopic Rack	Yes	Yes
Note: The CD2-10BDL
and DINCD2-8B
container models are
not validated for use in
100% Ethylene Oxide
sterilization	Optional Protective Plate	Yes	No
	Filter	NST series	NST series
	Data Cards	MD1-1	MD1-1
	Tamper Evident Arrow	White AS Series	Yellow AG Series
	Stack Height	3 max	No stacking
Type of Container	Contents/Configuration	Pre-Vacuum Steam	100% Ethylene Oxide
STERRAD Compatible
Containers	Materials	Radel
Stainless Steel
Aluminum
Silicone	Radel
Stainless Steel
Aluminum
Silicone
	Maximum Total Weight	25 lbs.	15 lbs.
	Non Stacking Baskets	Yes	Yes
	Stacking Baskets	Yes	No
	Lumen: 2.68mm (ID) x
450mm (L)	Yes, maximum 2	No
	Lumen: 3.0mm (ID) x
400mm (L)	Yes, maximum 2	Yes
	Occluded/Mated
Challenge	Yes	Yes
	Silicone Support Bars	Yes	Yes
	Silicone Mat	Yes	No
	Laparoscopic Rack	Yes	Yes
	Optional Protective Plate	Yes	No
	Filter	NST Series	NST Series
	Data Cards	MD1-1	MD1-1
	Tamper-Evident Arrow	White AS Series	Yellow AG Series
	Stack Height	3 Maximum	No Stacking
	Materials	Radel
Stainless Steel
Aluminum
Silicone	Radel
Stainless Steel
Aluminum
Silicone
	Maximum Total
Container System
Weight	25 lbs.	15 lbs.

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| Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb.) |
|-----------------|--------------------------|--------------------------|---------------------------|
| CD0-4C | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.4 |
| CD1-4C | Half Length Container | 11.8 x 12.4 x 4.5 | 4.8 |
| CD1-5C | Half Length Container | 11.8 x 12.4 x 5.3 | 5.0 |
| CD1-6C | Half Length Container | 11.8 x 12.4 x 6.1 | 5.2 |
| CD2-4C | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.4 |
| CD2-5C | Mid Length Container | 19.2 x 12.4 x 5.3 | 6.7 |
| CD2-6C | Mid Length Container | 19.2 x 12.4 x 6.1 | 6.9 |
| CD2-8C | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.3 |
| CD3-4C | Full Length Container | 23.1 x 12.4 x 4.5 | 7.8 |
| CD3-5C | Full Length Container | 23.1 x 12.4 x 5.3 | 7.9 |
| CD3-6C | Full Length Container | 23.1 x 12.4 x 6.1 | 8.2 |
| CD3-7C | Full Length Container | 23.1 x 12.4 x 7.0 | 8.5 |

the country of the count

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| Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb.) |
|-----------------|---------------------------|--------------------------|---------------------------|
| CD7-5C | Extra Long Container | 25.2 x 12.4 x 5.9 | 8.5 |
| CD7-6C | Extra Long Container | 25.2 x 12.4 x 6.7 | 8.8 |
| CD7-9C | Extra Long Container | 25.2 x 12.4 x 8.4 | 9.7 |
| CD4-3C | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5C | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.2 |
| CD5-3C | Large Narrow Container | 28.1 x 11.2 x 5.0 | 8.4 |
| CD5-61C | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.1 |
| CD0-3C | Mini Container | 10.2 x 7.2 x 3.2 | 2.5 |
| CD6-6C | Retractor Container | 26.5 x 17.0 x 6.9 | 12.4 |
| CD1-7CDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.3 |
| CD1-8CDL | Half Length Container | 11.9 x 12.5 x 8.3 | 5.5 |
| CD2-7CDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.1 |
| CD2-10CDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD3-8CDL | Full Length Container | 23.1 x 12.5 x 7.8 | 8.8 |
| CD3-9CDL | Full Length Container | 23.1 x 12.5 x 8.8 | 8.6 |
| DINCD3-5C | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 7.9 |
| DINCD3-6C | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 8.2 |
| DINCD3-7C | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 8.5 |
| DINCD2-5C | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 6.7 |
| DINCD2-6C | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 6.9 |
| DINCD2-8C | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.3 |
| DINCD1-5C | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.0 |
| DINCD1-6C | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.2 |

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contraction and consisted to

: : : : :

| Catalog

Code	Description	Container Dimension (in)	Container Weight (lb.)
CD0-4B	Quarter Length Container	9.5 x 12.4 x 3.8	3.7
CD1-4B	Half Length Container	11.8 x 12.4 x 4.5	5.2
CD1-5B	Half Length Container	11.8 x 12.4 x 5.3	5.5
CD1-6B	Half Length Container	11.8 x 12.4 x 6.1	5.7
CD2-4B	Mid Length Container	19.2 x 12.4 x 4.5	6.8
CD2-5B	Mid Length Container	19.2 x 12.4 x 5.3	7.1
CD2-6B	Mid Length Container	19.2 x 12.4 x 6.1	7.4
CD2-8B	Mid Length Container	19.2 x 12.4 x 7.8	7.8
CD3-4B	Full Length Container	23.1 x 12.4 x 4.5	8.5
CD3-5B	Full Length Container	23.1 x 12.4 x 5.3	8.8
CD3-6B	Full Length Container	23.1 x 12.4 x 6.1	9.0
CD3-7B	Full Length Container	23.1 x 12.4 x 7.0	9.4
CD7-5B	Extra Long Container	25.2 x 12.4 x 5.9	9.0
CD7-6B	Extra Long Container	25.2 x 12.4 x 6.7	9.4
CD7-9B	Extra Long Container	25.2 x 12.4 x 8.4	10.0

ﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ

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| Catalog
Code | Description | Container Dimension (in) | Container
Weight (lb.) |
|-----------------|---------------------------|--------------------------|---------------------------|
| CD4-3B | Small Narrow Container | 20.8 x 7.3 x 3.9 | 4.5 |
| CD4-5B | Small Narrow Container | 20.8 x 7.3 x 5.2 | 5.0 |
| CD5-3B | Large Narrow Container | 28.1 x 11.2 x 5.0 | 9.1 |
| CD5-61B | Large Narrow Container | 28.1 x 11.2 x 6.4 | 9.5 |
| CD0-3B | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |
| CD6-6B | Retractor Container | 26.5 x 17.0 x 6.9 | 13.9 |
| CD1-7BDL | Half Length Container | 11.9 x 12.5 x 7.5 | 5.8 |
| CD1-8BDL | Half Length Container | 11.9 x 12.5 x 8.3 | 6.0 |
| CD2-10BDL | Mid Length Container | 19.2 x 12.5 x 9.4 | 8.2 |
| CD2-7BDL | Half Length Container | 19.2 x 12.5 x 7.0 | 7.5 |
| CD3-8BDL | Full Length Container | 23.1 x 12.5 x 7.8 | 9.6 |
| CD3-9BDL | Full Length Container | 23.1 x 12.5 x 8.8 | 9.9 |
| DINCD3-5B | Full Length DIN Container | 23.1 x 11.4 x 5.4 | 8.8 |
| DINCD3-6B | Full Length DIN Container | 23.1 x 11.4 x 6.1 | 9.0 |
| DINCD3-7B | Full Length DIN Container | 23.1 x 11.4 x 7.1 | 9.4 |
| DINCD2-5B | Mid Length DIN Container | 19.2 x 11.4 x 5.4 | 7.1 |
| DINCD2-6B | Mid Length DIN Container | 19.2 x 11.4 x 6.1 | 7.4 |
| DINCD2-8B | Mid Length DIN Container | 19.2 x 11.4 x 7.8 | 7.8 |
| DINCD1-5B | Half Length DIN Container | 11.6 x 11.4 x 5.4 | 5.5 |
| DINCD1-6B | Half Length DIN Container | 11.6 x 11.4 x 6.1 | 5.7 |

STERRAD Style Containers

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| Catalog
Code | Description | Container Dimension (In) | Container
Weight (lb.) |
|-----------------|--------------------------------|--------------------------|---------------------------|
| CD0-4ST | Quarter Length Container | 9.5 x 12.4 x 3.8 | 3.7 |
| CD1-4ST | Half Length Container | 11.8 x 12.4 x 4.5 | 5.2 |
| CD1-5ST | Half Length Container | 11.8 x 12.4 x 5.3 | 5.4 |
| CD1-6ST | Half Length Container | 11.8 x 12.4 x 6.1 | 5.6 |
| CD2-4ST | Mid Length Container | 19.2 x 12.4 x 4.5 | 6.8 |
| CD2-5ST | Mid Length Container | 19.2 x 12.4 x 5.3 | 7.0 |
| CD2-6ST | Mid Length Container | 19.2 x 12.4 x 6.1 | 7.2 |
| CD2-8ST | Mid Length Container | 19.2 x 12.4 x 7.8 | 7.7 |
| CD3-4ST | Full Length Container | 23.1 x 12.4 x 4.5 | 8.4 |
| CD3-5ST | Full Length Containers | 23.1 x 12.4 x 5.3 | 8.6 |
| CD3-6ST | Full Length Containers | 23.1 x 12.4 x 6.1 | 8.9 |
| CD3-7ST | Full Length Containers | 23.1 x 12.4 x 7.0 | 9.3 |
| CD4-3ST | Small Narrow Shallow Container | 20.8 x 7.3 x 3.9 | 4.2 |
| CD4-5ST | Small Narrow Container | 20.8 x 7.3 x 5.2 | 4.8 |
| CD5-3ST | Large Narrow Shallow Container | 28.1 x 11.2 x 5.0 | 8.9 |
| CD5-61ST | Large Narrow Shallow Container | 28.1 x 11.2 x 6.4 | 9.4 |
| CD0-3ST | Mini Container | 10.2 x 7.2 x 3.2 | 2.6 |

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