Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- PrimaLOK FF 4.5 mm Cannulated Tap FDA UDI
- Model / Reference
- 800-1202 FDA UDI
- Description
- PrimaLOK FF 4.5 mm Cannulated Tap FDA UDI
Identifiers
- Catalog Number
- 800-1202 FDA UDI
- Primary DI / UDI-DI
- 00845694037631 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- U 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
OsteoMed by Osteomed Corp. — Class U — 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osteomed Corp.
Sources (1)
- FDA UDI ff2825bc-f6e7-48ae-94bc-f968a170364e 36 fields · synced May 30, 2026