Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- PrimaLIF LLIF 9mm x 22mm Parallel Trial FDA UDI
- Model / Reference
- 813-1009 FDA UDI
- Description
- PrimaLIF LLIF 9mm x 22mm Parallel Trial FDA UDI
Identifiers
- Catalog Number
- 813-1009 FDA UDI
- Primary DI / UDI-DI
- 00845694040532 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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 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
- Osteomed Corp.
Sources (1)
- FDA UDI cb907ade-3f3b-42cd-8fe5-98669b2de44a 36 fields · synced May 31, 2026