Identity
- Trade Name
- GENOSS Collagen Membrane FDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- Resorbable Dental Barrier membrane FDA UDI
- Model / Reference
- GCM2530 FDA UDI
- Description
- Resorbable Dental Barrier membrane FDA UDI
Identifiers
- Catalog Number
- GCM2530 FDA UDI
- Primary DI / UDI-DI
- 08809324765716 FDA UDI
- 510(k) Number
- K102307 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
- 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
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 30 Millimeter FDA UDIWidth — 25 Millimeter FDA UDI
Category: Collagen dental regeneration membrane
GENOSS Collagen Membrane by Genoss — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Collagen dental regeneration membrane.
- Neogen Collagen Flex S — COLLAGEN MATRIX, INC. · Class II
- GuidOss — Nibec Co., Ltd. · Class II
- PLENA FLEX — COLLAGEN MATRIX, INC. · Class II
- Neogen Collagen Firm L — COLLAGEN MATRIX, INC. · Class II
- OUSIA bioMAINTAIN — ACE SURGICAL SUPPLY CO., INC. · Class II
- ORAFOAM-PKG-18 — SALVIN DENTAL SPECIALTIES, LLC · Class II
- Kontour Matrix — Matricel GmbH · Class II
- Reguarde — COLLAGEN MATRIX, INC. · Class II
Cleared under the same submission
K102307 also covers:
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- GENOSS Collagen Membrane — Genoss
- Straumann Membrane Plus — Genoss
- Straumann Membrane Plus — Genoss
- Straumann Membrane Plus — Genoss
- Straumann Membrane Plus — Genoss
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
- Genoss
Sources (1)
- FDA UDI f109c162-1b89-4349-9504-6223d9f4ca25 37 fields · synced May 31, 2026