Fibracol® Plus

FDA UDI

Class U (US FDA UDI)

by Systagenix Wound Management, Limited

Identity

Trade Name: FIBRACOL® PLUS FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Collagen Wound Dressing with Alginate FDA UDI
Model / Reference: 2983 FDA UDI
Description: Collagen Wound Dressing with Alginate FDA UDI

Identifiers

Catalog Number: 2983 FDA UDI
Primary DI / UDI-DI: 15051978001102 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 10.2 Centimeter FDA UDI
Length — 22.2 Centimeter FDA UDI

Category: Animal-derived wound matrix dressing

Fibracol® Plus by Systagenix Wound Management, Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Systagenix Wound Management, Limited

Sources (1)

FDA UDI 6ca98f03-cd82-4937-b764-e98ec35e5b8e 36 fields · synced Jun 1, 2026