Identity
- Trade Name
- Endoform™ Natural Restorative Bioscaffold FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Endoform™ Natural is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with wound exudate or sterile saline, Endoform Natural transforms into a soft conforming sheet, which is incorporated into the wound over time. FDA UDI
- Model / Reference
- 529311 FDA UDI
- Description
- Endoform™ Natural is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with wound exudate or sterile saline, Endoform Natural transforms into a soft conforming sheet, which is incorporated into the wound over time. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421906017281 FDA UDI
- 510(k) Number
- K092096 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
Yes
FDA UDI
MR Safe FDA UDI
Category: Animal-derived wound matrix dressing
Endoform™ Natural Restorative Bioscaffold 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
K092096 also covers:
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform Natural Dermal Template — Aroa Biosurgery
- Endoform™ Natural Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Natural Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Natural Restorative Bioscaffold — Aroa Biosurgery
- Endoform™ Natural 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aroa Biosurgery
Sources (1)
- FDA UDI 9187194c-c1b9-4192-9493-dbc29326edec 36 fields · synced May 30, 2026