Fortify Flowable

FDA UDI

Class U (US FDA UDI)

by Cook Biotech Incorporated

Identity

Trade Name: Fortify Flowable FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Fortify Flowable Extracellular Matrix FDA UDI
Model / Reference: G59074 FDA UDI
Description: Fortify Flowable Extracellular Matrix FDA UDI

Identifiers

Catalog Number: FFM-01-KIT FDA UDI
Primary DI / UDI-DI: 00827002590748 FDA UDI
510(k) Number: K160136 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

Yes

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

Fortify Flowable by Cook Biotech Incorporated — 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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Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · 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

Cleared under the same submission

K160136 also covers:

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: Cook Biotech Incorporated

Sources (1)

FDA UDI b135c54e-76b0-4c23-8596-d23cca13762f 37 fields · synced May 30, 2026