Identity
- Trade Name
- GEM Cap™ FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Resorbable Collagen Membrane, 12mm x 16mm FDA UDI
- Model / Reference
- LBCAP1216 FDA UDI
- Description
- Resorbable Collagen Membrane, 12mm x 16mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001118071 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
Dimensions & Sizes
- Size
- Width — 16 Millimeter FDA UDILength — 12 Millimeter FDA UDI
GEM Cap™ 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 ffa662f9-1c22-431c-b0ec-7d7f5919e832 35 fields · synced May 31, 2026