MicroMatrix®

FDA UDI

Class U (US FDA UDI)

by Acell, Inc.

Identity

Trade Name: MicroMatrix® FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: MicroMatrix® Flex 5cc FDA UDI
Model / Reference: MMFX05 FDA UDI
Description: MicroMatrix® Flex 5cc FDA UDI

Identifiers

Catalog Number: MMFX05 FDA UDI
Primary DI / UDI-DI: 00386190002056 FDA UDI
510(k) Number: K230980 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Animal-derived wound matrix dressing

MicroMatrix® by Acell, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Animal-derived wound matrix dressing.

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Solventum™ Promogran™ — Solventum US LLC · U
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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: Acell, Inc.

Sources (1)

FDA UDI b97ff30c-3e68-45bf-a238-5b15de2ddd4a 38 fields · synced Jun 6, 2026