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Endoform Myriad

FDA UDI

Class U (US FDA UDI)

by Aroa Biosurgery

Identity

Trade Name
Endoform Myriad FDA UDI
Generic Name
Animal-derived wound matrix dressing FDA UDI
Device Name
Myriad 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 surround the tissue if desired. FDA UDI
Model / Reference
MR03LG1020 FDA UDI
Description
Myriad 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 surround the tissue if desired. FDA UDI

Identifiers

Catalog Number
SR03LG1020US FDA UDI
Primary DI / UDI-DI
09421905067416 FDA UDI
510(k) Number
K162461 FDA UDI
K171231 FDA UDI
FDA Product Code
KGN FDA UDI
FTL 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
MRI Safety
MR Safe FDA UDI

Endoform Myriad 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 5a8bcafd-daed-47cc-9e5e-1ee2b1536eec 39 fields · synced May 31, 2026