Identity
- Trade Name
- OSTEOPREP FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- 4MM STRAIGHT RASP, OSTEOPREP FDA UDI
- Model / Reference
- 25.1007 FDA UDI
- Description
- 4MM STRAIGHT RASP, OSTEOPREP FDA UDI
Identifiers
- Catalog Number
- 25.1007 FDA UDI
- Primary DI / UDI-DI
- 30845854037816 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Osteoprep by Conmed Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI a3f5fa6b-ad2a-460c-9845-901342aa4d63 37 fields · synced Jun 6, 2026