Identity
- Trade Name
- BAHADIR USA FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- PERFORATED TRAY WITH HINGED LID 280X170X60MM FDA UDI
- Model / Reference
- Y581.28 FDA UDI
- Description
- PERFORATED TRAY WITH HINGED LID 280X170X60MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- B060Y581280 FDA UDI
- 510(k) Number
- K131407 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument tray, reusable
Bahadir Usa by Bahadir Usa Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
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Cleared under the same submission
K131407 also covers:
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
- BAHADIR USA — BAHADIR USA LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bahadir Usa Llc
Sources (1)
- FDA UDI 25fbe0de-8a5d-44c9-94ed-80bab3d7b0e5 34 fields · synced May 31, 2026