Identity
- Trade Name
- DuraMatrix-Onlay Conform FDA UDI
- Generic Name
- Dura mater graft, bovine FDA UDI
- Device Name
- Collagen Dural Regeneration Matrix FDA UDI
- Model / Reference
- DMOC13 FDA UDI
- Description
- Collagen Dural Regeneration Matrix FDA UDI
Identifiers
- Catalog Number
- DMOC13 FDA UDI
- Primary DI / UDI-DI
- 00813954026084 FDA UDI
- FDA Product Code
- GXQ FDA UDI
- GMDN Term
- Dura mater graft, bovine FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5910 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dura mater graft, bovine
DuraMatrix-Onlay Conform by Collagen Matrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dura mater graft, bovine.
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- DuraGen® — Integra Lifesciences Corp. · Class II
- DURA-GUARD Dural Repair Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
- DURA-GUARD Dural Repair Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II
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
- Collagen Matrix, Inc.
Sources (1)
- FDA UDI d19d1a35-e123-4e53-9627-3a82358bc60a 36 fields · synced Jun 8, 2026