CellerateRX® Hydrolyzed Collagen Gel 28 grams

FDA UDI

Class U (US FDA UDI)

by Sanara Medtech Inc.

Identity

Trade Name: CellerateRX® Hydrolyzed Collagen Gel 28 grams FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: CellerateRX® Gel is Type I bovine hydrolyzed collagen and contains no additives. The gel is approximately 65% hydrolyzed collagen and 35% purified water. FDA UDI
Model / Reference: CRXG-28GMEA FDA UDI
Description: CellerateRX® Gel is Type I bovine hydrolyzed collagen and contains no additives. The gel is approximately 65% hydrolyzed collagen and 35% purified water. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850017274099 FDA UDI
510(k) Number: K955506 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

Yes

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

Category: Animal-derived wound matrix dressing

CellerateRX® Hydrolyzed Collagen Gel 28 grams by Sanara Medtech Inc. — 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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DermaCol/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC · U
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

K955506 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: Sanara Medtech Inc.

Sources (1)

FDA UDI 8436ccb9-31f0-456e-a234-dc4f4395faad 35 fields · synced Jun 8, 2026