Identity
- Trade Name
- Gentell FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Collagen wound dressing, 7"x7" FDA UDI
- Model / Reference
- GEN-18700 FDA UDI
- Description
- Collagen wound dressing, 7"x7" FDA UDI
Identifiers
- Catalog Number
- GEN-18700 FDA UDI
- Primary DI / UDI-DI
- 00361554003207 FDA UDI
- 510(k) Number
- K231152 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- Animal-derived wound matrix dressing FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Animal-derived wound matrix dressing
Gentell by Gentell — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Animal-derived wound matrix dressing.
- PuraPly™ Antimicrobial XT Wound Matrix — ORGANOGENESIS INC. · Class I
- DermaCol/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC · U
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
- Kerecis® GraftGuide® — KERECIS hf. · U
- HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- Solventum™ Promogran™ — Solventum US LLC · U
- Simpurity — SAFE N SIMPLE LLC · U
- ProgenaMatrix — Progenacare Global, LLC · U
Cleared under the same submission
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gentell
Sources (1)
- FDA UDI 270d0962-a443-480b-95c8-b726e5beeb31 35 fields · synced May 30, 2026