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510(k) Data Aggregation
K Number
K131407Device Name
BAHADIR STERILIZATION TRAYS
Manufacturer
BAHADIR USA CORP.
Date Cleared
2014-08-12
(454 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
BAHADIR USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process.
- 3 containers MAXIMUM can be stacked.
- Stacked containers may not exceed a maximum of 18 inches
Immediate Use only intended for non-stacked configurations during the sterilization process. Immediate Use sterilized devices cannot be stored.
The devices included in this submission are to be used with a pre-vacuum, three pulse of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.
Device Description
The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:
| Flat Size Y310.05A | Mini Size Y410.04A | Dental Size Y510.04A |
|--------------------|--------------------|----------------------|
| Flat Size Y310.08A | Mini Size Y410.07A | Dental Size Y510.06A |
| Flat Size Y311.08A | Mini Size Y410.10A | Dental Size Y510.08A |
| | Mini Size Y411.04A | Dental Size Y510.10A |
| | Mini Size Y411.07A | Dental Size Y510.13A |
| | Mini Size Y411.10A | Dental Size Y511.04A |
| | | Dental Size Y511.06A |
| | | Dental Size Y511.08A |
| | | Dental Size Y511.10A |
| Full size Y110.10W | 3/4 size Y210.10W | 1/2 size Y310.10W |
| Full size Y111.10W | 3/4 size Y210.13W | 1/2 size Y310.13W |
| Full size Y110.13W | 3/4 size Y210.15W | 1/2 size Y310.15W |
| Full size Y111.13W | 3/4 size Y211.10W | 1/2 size Y310.20W |
| Full size Y110.15W | 3/4 size Y211.13W | 1/2 size Y310.26W |
| Full size Y111.15W | 3/4 size Y211.15W | 1/2 size Y311.10W |
| Full size Y110.20W | | 1/2 size Y311.13W |
| Full size Y111.20W | | 1/2 size Y311.15W |
| Full size Y111.26W | | 1/2 size Y311.20W |
| Wide size Y110.62W | | 1/2 size Y311.26W |
| Wide size Y110.68W | | |
| Wide Size Y111.62W | | |
| Wide Size Y111.68W | | |
The devices are composed of anodized aluminum alloy with lid colors as follows: green, yellow/ qolden orange, red, black and natural aluminum.
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K Number
K112090Device Name
BAHADIR STERILIZATION TRAYS
Manufacturer
BAHADIR USA CORP.
Date Cleared
2012-06-07
(322 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
BAHADIR USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length
% Size Y211.10W % Size Y211.13W % Size Y211.15W
(% Max Load Wt. 12.5 Ibs
including basket & instruments)
Lumen Size min 1mm diameter
½ Size Y311.26W
(½ Size Max Load Wt. 9.25 Ibs including basket & instruments) Lumen size min 1mm diameter X 200mm length
½ Size Y311.10W
½ Size Y311.13W
½ Size Y311.15W
1/2 Size Y311.20W
Device Description
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices subject to this submission are as follows:
Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W
% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W
The devices are composed of anodized aluminum (this does not include colored anodized lids).
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K Number
K102146Device Name
BAHADIR STERILIZATION TRAYS
Manufacturer
BAHADIR USA CORP.
Date Cleared
2010-11-18
(111 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
BAHADIR USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.
The devices (natural aluminum color containers and lids) subject to this submission are as follows:
Full Size 1/1 Y110.20 Full Size 1/1 Y110.15 Full Size 1/1 Y110.13 Full Size 1/1 Y110.10 3/4 Size Y210.10 34 Size Y210.15 3/4 Size Y210.13 1/2 Size Y310.20 1/2 Size Y310.15 1/2 Size Y310.13 1/2 Size Y310.10
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for 34 size, and 9.25 Ibs for 1/2 size. The sterilization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments.
The subject trays are not validated for use with lumened devices, air driven instruments, power systems, or cannulized instruments.
Device Description
The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes. Stacking during sterilization is not recommended.
The devices subject to this submission are as follows:
Full Size 1/1 Y110.20 (580 x 280 x 200mm) Full Size 1/1 Y110.15 (580 x 280 x 150mm) Full Size 1/1 Y110.13 (580 x 280 x 135mm) Full Size 1/1 Y110.10 (580 x 280 x 100mm) 3/4 Size Y210.15 (465 x 280 x 150mm) 3/4 Size Y210.13 (465 x 280 x 135mm) 3/4 Size Y210.10 (465 x 280 x 100mm) 1/2 Size Y310.20 (285 x 280 x 200mm) 1/2 Size Y310.15 (285 x 280 x 150mm) 1/2 Size Y310.13 (285 x 280 x 135mm) 1/2 Size Y310.10 (285 x 280 x 100mm)
The maximum load weight is 24.75 lbs for full size, 12.5 lbs for ¾ size, and 9.25 lbs for 1/2 size.
The devices are composed of anodized aluminum (this does not include colored anodized lids).
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