Identity
- Trade Name
- SCHANZ PIN FASTENER OUTER CASE FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- SCHANZ PIN FASTENER OUTER CASE FDA UDI
- Model / Reference
- 303-9001 FDA UDI
- Description
- SCHANZ PIN FASTENER OUTER CASE FDA UDI
Identifiers
- Catalog Number
- 303-9001 FDA UDI
- Primary DI / UDI-DI
- 00816950029950 FDA UDI
- FDA Product Code
- LRP FDA UDI
- GMDN Term
- Surgical instrument/implant rack 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
MR Conditional FDA UDI
Category: Surgical instrument/implant rack
Schanz Pin Fastener Outer Case by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 312be7bd-accc-4f35-bb3c-47909e7e9292 35 fields · synced May 30, 2026