(259 days)
Not Found
No
The device is a physical sterilization container system and the description focuses on its materials, compatibility with sterilization processes, and accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is a sterilization container intended to enclose medical devices for sterilization and maintain their sterility, not to directly treat or diagnose a medical condition.
No.
The device is a sterilization container system designed to enclose other medical devices for sterilization and maintain their sterility, not to diagnose medical conditions.
No
The device is a physical container system made of aluminum and polypropylene filters, designed to hold other medical devices during sterilization. It is clearly a hardware device.
Based on the provided text, the Aesculap Sterilcontainer S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "reusable sterilization container system... intended to be used to enclose another medical device that is to be sterilized by a healthcare provider." Its purpose is to facilitate sterilization and maintain the sterility of other medical devices.
- Definition of IVD: An IVD device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The Aesculap Sterilcontainer S does not perform any tests on biological samples. It is a container used in the process of sterilizing other medical devices.
Therefore, the Aesculap Sterilcontainer S falls under the category of a medical device used for sterilization and storage, not an IVD.
N/A
Intended Use / Indications for Use
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
The Sterilcontainer S is recommended for surface and lumens:
STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L STERRAD NX standard cycle, stainless steel lumens ≥ 2mm I.D. x ≤ 400mm L STERRAD NX advanced cycle, stainless steel lumens ≥ 1mm I.D. x ≤ 500mm L STERRAD 100NX standard cycle, stainless steel lumens ≥ 0.7mm I.D. x ≤ 500mm L STERRAD 100NX flex cycle, porous lumens (flexible endoscope) ≥ 1mm I.D. x ≤ 850mm L
30 days of shelf life testing has been conducted for the Sterilicontainer S.
The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.
Product codes
FRG
Device Description
The Aesculap Sterilcontainer S is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the STERRAD sterilization processes [200, NX (Standard cycle and Advanced cycle), and 100NX (Standard cycle and Flex cycle). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter. The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap Sterilcontainer S was completed. The Aesculap Sterilcontainer S was fully validated for STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KCA343
Page 1 of 5
| B. | 510(k) SUMMARY (as required by 21 CFR 807.92) | |
|---|---|---|
| Aesculap Sterilcontainer S for | ||
| STERRAD 200, STERRAD NX, and STERRAD NX100 | ||
| July 27, 2010 | ||
| COMPANY: | Aesculap®, Inc. | |
| 3773 Corporate Parkway | ||
| Center Valley, PA 18034 | ||
| Establishment Registration Number: 2916714 | JUL 2-7 2010 | |
| CONTACT: | Kathy A. Racosky | |
| 610-984-9291 (phone) | ||
| 610-791-6882 (fax) | ||
| TRADE NAME: | Aesculap Sterilcontainer 'S | |
| COMMON NAME: | Sterilization Container Wrap | |
| CLASSIFICATION NAME: | Wrap, Sterilization | |
| REGULATION NUMBER: | 880.6850 | |
| PRODUCT CODE: | FRG |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the SterilContainer S is substantially equivalent to:
- Aesculap STERRAD 100S Compatible Sterilcontainer (K040865), .
- SteriTite Universal Container System with MediTray Products for STERRAD 200, . STERRAD NX, Ozone 125L, Sterilization, and Prevacuum Steam Flash Sterilization (K080558).
DEVICE DESCRIPTION
The Aesculap Sterilcontainer S is designed as a container system that will allow for sterilization and storage of other medical devices. This container is designed to be compatible for use with the STERRAD sterilization processes [200, NX (Standard cycle and Advanced cycle), and 100NX (Standard cycle and Flex cycle). The container is made from non-anodized Aluminum and utilizes a disposable (single use) polypropylene filter. The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
1
INDICATIONS FOR USE:
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container has been validated with stainless steel lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
The Sterilcontainer S is recommended for surface and lumens:
STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L STERRAD NX standard cycle, stainless steel lumens ≥ 2mm I.D. x ≤ 400mm L STERRAD NX advanced cycle, stainless steel lumens ≥ 1mm I.D. x ≤ 500mm L STERRAD 100NX standard cycle, stainless steel lumens ≥ 0.7mm I.D. x ≤ 500mm L STERRAD 100NX flex cycle, porous lumens (flexible endoscope) ≥ 1mm I.D. x ≤ 850mm L
30 days of shelf life testing has been conducted for the Sterilicontainer S.
The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.
2
Page 3 of 5
| Item # | Description | Total loaded
container
weight (lbs) |
|-------------------|--------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 ½") | 21.46 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 |
| JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 14.42 |
| JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 14.42 |
| JM742 | ¾ Size Perforated Bottom 135mm (6") | 14.42 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 14.42 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 14.42 |
| JM342 | ½ Size Perforated Bottom 135mm (6") | 14.42 |
| JM344 | ½ Size Perforated Bottom 187mm (8") | 14.42 |
| JM094 | ¼ Size Perforated Bottom with Lid 65mm (2 ½") | 14.42 |
| JM096 | ¼ Size Perforated Bottom with Lid 130mm (5 1/8") | 14.42 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | ¾ Size Lid | |
| JM389 | ½ Size Lid | |
| See JM094 & JM096 | ¼ Size Lid | |
| JM020 | Extra Long Mini Lid | |
TABLE 1 ilContainer & Comp tible Containers in STERBAD 200
Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system.
TABLE 2 SterilContainer S Compatible Containers in STERRAD NX Standard and Advanced Cvcle
| Item # | Description | Total loaded
container weight
(lbs) |
|-------------------|--------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 ½") | 21.46 |
| JM740 | ¾ Size Perforated Bottom 90mm (4 ¼") | 13.85 |
| JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 13.85 |
| JM742 | ¾ Size Perforated Bottom 135mm (6") | 13.85 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 13.85 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 13.85 |
| JM094 | ¼ Size Perforated Bottom with Lid 65mm (2 ½") | 13.85 |
| JM096 | ½ Size Perforated Bottom with Lid 130mm (5 1/8") | 13.85 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | 3/4 Size Lid | |
| JM389 | ½ Size Lid | |
| See JM094 & JM096 | ¼ Size Lid | |
| JM020 | Extra Long Mini Lid | |
Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system.
3
Page 4 of 5
| TABLE 3 |
|---|
| SterilContainer S Compatible Containers in STERRAD 100NX |
| Standard Cycle |
.
| Item # | Description | Total loaded
container
weight (lbs) |
|-------------------|--------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 ½") | 21.46 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 |
| JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 13.85 |
| JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 13.85 |
| JM742 | ¾ Size Perforated Bottom 135mm (6") | 13.85 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 13.85 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 13.85 |
| JM342 | ½ Size Perforated Bottom 135mm (6") | 13.85 |
| JM344 | ½ Size Perforated Bottom 187mm (8") | 13.85 |
| JM094 | ¼ Size Perforated Bottom with Lid 65mm (2 ½") | 13.85 |
| JM096 | ¼ Size Perforated Bottom with Lid 130mm (5 1/8") | 13.85 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | ¾ Size Lid | |
| JM389 | ½ Size Lid | |
| See JM094 & JM096 | ¼ Size Lid | |
| JM020 | Extra Long Mini Lid | |
Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system.
TABLE 4 SterilContainer S Compatible Containers in STERRAD 100NX Flex Cycle
| Item # | Description | Total loaded
container
weight (lbs) |
|--------|------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 9.67 |
| JM441 | Full Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 9.67 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 9.67 |
| JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 9.67 |
| JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM742 | ¾ Size Perforated Bottom 135mm (6") | 9.67 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 9.67 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM342 | ½ Size Perforated Bottom 135mm (6") | 9.67 |
| JM344 | ½ Size Perforated Bottom 187mm (8") | 9.67 |
| JM489 | Full Size Lid | |
| JM789 | ¾ Size Lid | |
| JM389 | ½ Size Lid | |
Note: Full, ¾, and ½ size containers have been validated with 1 PTFE/PE lumen per container system.
4
TECHNOLIGICAL CHARACTERISTICS(compared to predicate(s)}
The Aesculap Sterilcontainer S is compatible for use in STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). The Sterilcontainer is offered in similar shapes and sizes as the predicate devices. The material used for the STERRAD Compatible Aesculap Sterilcontainer S is the same as that used to manufacture the predicate devices.
PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" for Aesculap Sterilcontainer S was completed. The Aesculap Sterilcontainer S was fully validated for STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). Sterilization Systems. This validation was conducted in accordance with FDA guidance and available AAMI standards by a qualified testing laboratory.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem resembling a caduceus, with three wave-like lines representing the department's mission of promoting health and well-being. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathy Racosky Regulatory Affairs Specialist AESCULAP, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K093493
Trade/Device Name: AESCULAP Sterilcontainer S Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 29, 2010 Received: June 30, 2010
JUL 2-7 2010
Dear Ms. Racosky:
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.
6
Page 2- Ms. Racosky
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Luong
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
7
INDICATIONS FOR USE STATEMENT
JUL 27 2010
510(k) Number:
Device Name: Aesculap Sterilcontainer S
Indications for Use:
The Aesculap Sterilcontainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and disposable polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This confainer has been validated with stainless steel lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the STERRAD 200, STERRAD NX (Standard cycle and Advanced cycle), and STERRAD 100NX (Standard cycle and Flex cycle). The Steriicontainer S System includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders.
The Stericontainer S is recommended for surface and lumens:
STERRAD 200, stainless steel lumens ≥ 3mm I.D. x ≤ 400mm L STERRAD NX standard cycle, stainless steel lumens ≥ 2mm 1.D. x ≤ 400mm L STERRAD NX advanced cycle, stainless steel lumens ≥ 1mm 1.D. x ≤ 500mm L STERRAD 100NX standard cycle, stainless steel lumens ≥ 0.7mm |.D. x ≤ 500mm L STERRAD 100NX flex cycle, porous lumens (flexible endoscope) ≥ 1mm I.D. x ≤ 850mm L
30 days of shelf life testing has been conducted for the Sterilicontainer S.
The attached tables identify which products may be sterilized in which STERRAD sterilization cycle.
Prescription Use
and/or . Over-the-Counter Use __
(per 21 CFR 801 Subpart D)
(per 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 3
(Division Sign-Uff) (Division Sign-On)
Division of Anesthesiology, General Hospital
8
| Item # | Description | Total loaded
container
weight (lbs) |
|-------------------|--------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 ¼") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 ½") | 21.46 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 |
| JM740 | ¾ Size Perforated Bottom 90mm(4 ¼") | 14.42 |
| JM741 | ¾ Size Perforated Bottom 120mm (5 ½") | 14.42 |
| JM742 | ¾ Size Perforated Bottom 135mm (6") | 14.42 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 14.42 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 14.42 |
| JM342 | ½ Size Perforated Bottom 135mm (6") | 14.42 |
| JM344 | ½ Size Perforated Bottom 187mm (8") | 14.42 |
| JM094 | ¼ Size Perforated Bottom with Lid 65mm (2 ½") | 14.42 |
| JM096 | ¼ Size Perforated Bottom with Lid 130mm (5 1/8") | 14.42 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | ¾ Size Lid | |
| JM389 | ½ Size Lid | |
| See JM094 & JM096 | ¼ Size Lid | |
| JM020 | Extra Long Mini Lid | |
TABLE 1 SterilContainer S Compatible Containers in STERRAD 200
Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system.
TABLE 2 SterilContainer S Compatible Containers in STERRAD NX Standard and Advanced Cycle
| Item # | Description | Total loaded
container weight
(lbs) |
|-------------------|----------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 1/4") | 21,46 |
| JM441 | Full Size Perforated Bottom 120mm (5 1/2") | 21.46 |
| JM740 | 3/4 Size Perforated Bottom 90mm (4 1/4") | 13.85 |
| JM741 | 3/4 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM742 | 3/4 Size Perforated Bottom 135mm (6") | 13.85 |
| JM340 | 1/2 Size Perforated Bottom 90mm (4 1/4") | 13.85 |
| JM341 | 1/2 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM094 | 1/4 Size Perforated Bottom with Lid 65mm (2 1/2") | 13.85 |
| JM096 | 1/4 Size Perforated Bottom with Lid 130mm (5 1/8") | 13.85 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | 3/4 Size Lid | |
| JM389 | ½ Size Lid | |
| See JM094 & JM096 | 1/4 Size Lid | |
| JM020 | Extra Long Mini Lid | |
Note: Full, ¼, ½, and ¼ size containers have been validated with 5 stainless steel lumens per container system. The Extra Long Mini container has been validated with 2 stainless steel lumens per container system.
9
TABLE 3 SterilContainer S Compatible Containers in STERRAD 100NX Standard Cycle
| Item # | Description | Total loaded
container
weight (lbs) |
|-------------------|----------------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 1/4") | 21.46 |
| JM441 | Full Size Perforated Bottom 120mm (5 1/2") | 21.46 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 21.46 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 21.46 |
| JM740 | 3/4 Size Perforated Bottom 90mm(4 1/4") | 13.85 |
| JM741 | 3/4 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM742 | 3/4 Size Perforated Bottom 135mm (6") | 13.85 |
| JM340 | 1/2 Size Perforated Bottom 90mm (4 1/4") | 13.85 |
| JM341 | 1/2 Size Perforated Bottom 120mm (5 1/2") | 13.85 |
| JM342 | 1/2 Size Perforated Bottom 135mm (6") | 13.85 |
| JM344 | 1/2 Size Perforated Bottom 187mm (8") | 13.85 |
| JM094 | 1/4 Size Perforated Bottom with Lid 65mm (2 1/2") | 13.85 |
| JM096 | 1/4 Size Perforated Bottom with Lid 130mm (5 1/8") | 13.85 |
| JM021 | Extra Long Mini Bottom 73mm (3") | 7.64 |
| JM489 | Full Size Lid | |
| JM789 | 3/4 Size Lid | |
| JM389 | 1/2 Size Lid | |
| See JM094 & JM096 | 1/4 Size Lid | |
| JM020 | Extra Long Mini Lid | |
Note: Full, ¾, ½, and ¼ size containers have been validated with 5 stainless steel lumens per Note: I dir, %, 72, and 14 oize oonlainer has been validated with 2 stainless steel lumens per container system.
TABLE 4 SterilContainer S Compatible Containers in STERRAD 100NX Flex Cycle
| Item # | Description | Total loaded
container
weight (lbs) |
|--------|--------------------------------------------|-------------------------------------------|
| JM440 | Full Size Perforated Bottom 90mm (4 ½") | 9.67 |
| JM441 | Full Size Perforated Bottom 120mm (5 1/2") | 9.67 |
| JM442 | Full Size Perforated Bottom 135mm (6") | 9.67 |
| JM444 | Full Size Perforated Bottom 187mm (8") | 9.67 |
| JM740 | 3/4 Size Perforated Bottom 90mm(4 ½") | 9.67 |
| JM741 | 3/4 Size Perforated Bottom 120mm (5 1/2") | 9.67 |
| JM742 | 3/4 Size Perforated Bottom 135mm (6") | 9.67 |
| JM340 | ½ Size Perforated Bottom 90mm (4 ¼") | 9.67 |
| JM341 | ½ Size Perforated Bottom 120mm (5 ½") | 9.67 |
| JM342 | ½ Size Perforated Bottom 135mm (6") | 9.67 |
| JM344 | ½ Size Perforated Bottom 187mm (8") | 9.67 |
| JM489 | Full Size Lid. | |
| JM789 | 3/4 Size Lid | |
| JM389 | ½ Size Lid | |
Note: Full, ¾, and ½ size containers have been validated with 1 PTFE/PE lumen per container system.
Page 3 ol 3