Endoform™ Antimicrobial Restorative Bioscaffold

FDA UDI

Class U (US FDA UDI)

by Aroa Biosurgery

Identity

Trade Name: Endoform™ Antimicrobial Restorative Bioscaffold FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Endoform™ Antimicrobial is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue and incorporating approximately 12 ug/cm2 (~0.3% w/w) ionic silver, intended to inhibit colonization of the device. 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 exudate or sterile saline, Endoform Antimicrobial transforms into a soft conforming sheet, which is naturally incorporated into the wound over time. FDA UDI
Model / Reference: 629302 FDA UDI
Description: Endoform™ Antimicrobial is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue and incorporating approximately 12 ug/cm2 (~0.3% w/w) ionic silver, intended to inhibit colonization of the device. 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 exudate or sterile saline, Endoform Antimicrobial transforms into a soft conforming sheet, which is naturally incorporated into the wound over time. FDA UDI

Identifiers

Primary DI / UDI-DI: 09421906017427 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Animal-derived wound matrix dressing

Endoform™ Antimicrobial 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.

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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

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 28a7a930-a93e-4136-9c1a-12e2aec7d9b9 36 fields · synced May 30, 2026

Endoform™ Antimicrobial Restorative Bioscaffold

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)