Identity
- Trade Name
- OSTEOFLEX FDA UDI
- Generic Name
- Vertebral bone filler, non-bioabsorbable FDA UDI
- Model / Reference
- INTV-CEM FDA UDI
Identifiers
- Catalog Number
- INTV-CEM FDA UDI
- Primary DI / UDI-DI
- 03760177042933 FDA UDI
- FDA Product Code
- NDN FDA UDI
- GMDN Term
- Vertebral bone filler, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Osteoflex by Teknimed — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teknimed
Sources (1)
- FDA UDI ef885186-040d-4cbb-a6b7-dd16daa1379b 35 fields · synced May 30, 2026