Identity
- Trade Name
- DuraGen® FDA UDI
- Generic Name
- Dura mater biomatrix implant FDA UDI
- Device Name
- DuraGen® Dural Graft Matrix 1 PK 3x3 DOM FDA UDI
- Model / Reference
- ID3301 FDA UDI
- Description
- DuraGen® Dural Graft Matrix 1 PK 3x3 DOM FDA UDI
Identifiers
- Catalog Number
- ID-3301 FDA UDI
- Primary DI / UDI-DI
- 10381780023593 FDA UDI
- 510(k) Number
- K982180 FDA UDI
- FDA Product Code
- GXQ FDA UDI
- GMDN Term
- Dura mater biomatrix implant 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 biomatrix implant
DuraGen® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dura mater biomatrix implant.
- DuraMatrix Suturable — COLLAGEN MATRIX, INC. · Class II
- DuraMend-Onlay™ Plus — COLLAGEN MATRIX, INC. · Class II
- DuraMatrix Suturable — COLLAGEN MATRIX, INC. · Class II
- DuraMatrix-Onlay Plus — COLLAGEN MATRIX, INC. · Class II
- DuraMatrix-Onlay Plus — COLLAGEN MATRIX, INC. · Class II
- DuraMend-Onlay™ Plus — COLLAGEN MATRIX, INC. · Class II
- KBIO® Dura — COLLAGEN MATRIX, INC. · Class II
- DURAFORM — Cerenovus, Inc. · Class II
Cleared under the same submission
K982180 also covers:
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
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI bc075f09-8b14-4832-9ef1-b4af22b76f73 38 fields · synced May 30, 2026