Identity
- Trade Name
- GEM™ Synthetic Bone Graft FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Synthetic Mineral-Collagen Composite Bone Graft, 2.0cc (11mm x 21mm) FDA UDI
- Model / Reference
- LBSB200 FDA UDI
- Description
- Synthetic Mineral-Collagen Composite Bone Graft, 2.0cc (11mm x 21mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001118187 FDA UDI
- FDA Product Code
- NPL FDA UDI
- GMDN Term
- Collagen dental regeneration membrane FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
GEM™ Synthetic Bone Graft by Lynch Biologics, Llc — 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
- Lynch Biologics, Llc
Sources (1)
- FDA UDI cccbaab7-9869-48f6-b835-ade9a46c7428 34 fields · synced Jun 8, 2026