Identity
- Trade Name
- Endoform Antimicrobial Dermal Template FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment. FDA UDI
- Model / Reference
- 629311 FDA UDI
- Description
- Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment. FDA UDI
Identifiers
- Catalog Number
- 629311 FDA UDI
- Primary DI / UDI-DI
- 09421904065451 FDA UDI
- 510(k) Number
- K172318 FDA UDI
- FDA Product Code
- FRO 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
Yes
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
Dimensions & Sizes
- Size
- Width — 5 Centimeter FDA UDILength — 5 Centimeter FDA UDI
Category: Animal-derived wound matrix dressing
Endoform Antimicrobial Dermal Template by Aroa Biosurgery — 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
- 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
- INTEGRA® — Integra Lifesciences Corp. · U
Cleared under the same submission
K172318 also covers:
- Endoform Antimicrobial Dermal Template — Aroa Biosurgery
- Endoform Antimicrobial Dermal Template — Aroa Biosurgery
- Endoform Antimicrobial Dermal Template — Aroa Biosurgery
- Endoform Antimicrobial Dermal Template — Aroa Biosurgery
- Endoform Antimicrobial Dermal Template — Aroa Biosurgery
- Endoform Antimicrobial Dermal Template — Aroa Biosurgery
- Endoform™ Antimicrobial Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Antimicrobial Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Antimicrobial Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Antimicrobial Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Antimicrobial Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Antimicrobial Restorative Bioscaffold — Aroa Biosurgery
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 |
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Manufacturer
- Manufacturer
- Aroa Biosurgery
Sources (1)
- FDA UDI 00e5a8d7-67ce-4d02-8906-37365e72dd35 38 fields · synced May 31, 2026