Bahadir USA Y581.28
Bahadir USA Y581.28 is a Class I device made by Bahadir USA LLC, cleared under FDA 510(k) K131407 on 12 Aug 2014 and listed in FDA GUDID since 25 Feb 2020 (UDI-DI B060Y581280), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB060Y581280 | Date25 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131407 | Date12 Aug 2014 | StatusActive |
Official records
- FDA 510(k) database K131407
Across registries
- FDA 510(k) K131407 decided 12 Aug 2014 Active
- FDA GUDID UDI-DI B060Y581280 listed 25 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K131407
- Listed FDA GUDID B060Y581280
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bahadir USA
- Generic name
- Instrument tray, reusable
- Model / reference
- Y581.28
- Description
- PERFORATED TRAY WITH HINGED LID 280X170X60MM
- Primary DI / UDI-DI
- B060Y581280
- 510(k) Number
- FDA product code
- FSM
- GMDN term
- Instrument tray, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- GUDID distribution status
- In Commercial Distribution
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