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Endoform Surface

FDA UDI

Class U (US FDA UDI)

by Aroa Biosurgery

Identity

Trade Name
Endoform Surface FDA UDI
Generic Name
Animal-derived wound matrix dressing FDA UDI
Device Name
Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover, protect, and provide a moist wound environment. The device may be fixed, via sutures, staples, or tacks to the surrounding tissue, if desired. FDA UDI
Model / Reference
SR05LG1010 FDA UDI
Description
Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover, protect, and provide a moist wound environment. The device may be fixed, via sutures, staples, or tacks to the surrounding tissue, if desired. FDA UDI

Identifiers

Primary DI / UDI-DI
09421904065680 FDA UDI
510(k) Number
K162461 FDA UDI
K171231 FDA UDI
FDA Product Code
KGN FDA UDI
FTM FDA UDI
GMDN Term
Animal-derived wound matrix dressing FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
Not 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

Endoform Surface by Aroa Biosurgery — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K162461 also covers:

K171231 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aroa Biosurgery

Sources (1)

  • FDA UDI 172d0fb4-4296-4656-a56e-bd83b92104c3 38 fields · synced May 30, 2026