Identity
- Trade Name
- Biodesign FDA UDI
- Generic Name
- Dura mater biomatrix implant FDA UDI
- Device Name
- Biodesign Dural Graft FDA UDI
- Model / Reference
- G31091 FDA UDI
- Description
- Biodesign Dural Graft FDA UDI
Identifiers
- Catalog Number
- C-DUR-7X10 FDA UDI
- Primary DI / UDI-DI
- 00827002310919 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
Biodesign by Cook Biotech Incorporated — 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
- DuraGen® Plus — Integra Lifesciences Corp. · Class II
- DuraMend-Onlay™ Plus — COLLAGEN MATRIX, INC. · Class II
- DuraGen® Secure — Integra Lifesciences Corp. · Class II
Cleared under the same submission
K031850 also covers:
K160869 also covers:
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
- Biodesign — COOK BIOTECH INCORPORATED
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
- Cook Biotech Incorporated
Sources (1)
- FDA UDI 7afe9450-4f08-4be6-bbe0-cfe90c1573e1 37 fields · synced May 31, 2026