Identity
- Trade Name
- BIOSTOP FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- BIOSTOP G CEMENT RESTRICTOR STERILIZATION CASE FDA UDI
- Model / Reference
- 5463-62-500 FDA UDI
- Description
- BIOSTOP G CEMENT RESTRICTOR STERILIZATION CASE FDA UDI
Identifiers
- Catalog Number
- 546362500 FDA UDI
- Primary DI / UDI-DI
- 10603295174738 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
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Biostop by Depuy Orthopaedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI b7ab49ba-e245-48b9-94a5-392f9cd94691 36 fields · synced Jun 8, 2026