Identity
- Trade Name
- XENMATRIX FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- XenMatrix Surgical Graft, 6 cm x 16 cm (2.4" x 6.3"), Rectangle FDA UDI
- Model / Reference
- 1160616 FDA UDI
- Description
- XenMatrix Surgical Graft, 6 cm x 16 cm (2.4" x 6.3"), Rectangle FDA UDI
Identifiers
- Catalog Number
- 1160616 FDA UDI
- Primary DI / UDI-DI
- 00801741074356 FDA UDI
- FDA Product Code
- OXH FDA UDIFTM FDA UDIOWV FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Centimeter FDA UDIWidth — 16 Centimeter FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Xenmatrix by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
- Biodesign — COOK BIOTECH INCORPORATED · Class II
- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Meso BioMatrix® Acellular Peritoneum Matrix — DSM BIOMEDICAL, INC. · Class II
- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- Permacol — SOFRADIM PRODUCTION · Class II
- Gentrix® — ACELL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Davol Inc.
Sources (1)
- FDA UDI fd9d635f-aa84-43fa-817d-4ad591a90dcf 37 fields · synced May 31, 2026