CellerateRX Surgical

FDA UDI

Class U (US FDA UDI)

by Applied Nutritionals

Identity

Trade Name: CellerateRX Surgical FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: CellerateRX Surgical Hydrolyzed Collagen 5g Type I bovine collagen for chronic and acute wounds, partial and full thickness wounds, pressure injuries I-IV, venous stasis ulcers, arterial ulcers, diabetic ulcers, traumatic wounds, first and second degree burns, superficial wounds and surgical wounds. Sterile until opened. Store at room temperature. For use on moderately to heavily exudative wounds. Cleanse the wound per facility protocol. Apply CellerateRX Powder over the entire wound bed and the edges of the wound. Cover with an appropriate dressing. Reapply 2-3 times a week, or with each dressing change, taking care not to disrupt wound site. https://sanaramedtech.com/surgical/celleraterx-surgical/ FDA UDI
Model / Reference: WCI-05-SACRXP FDA UDI
Description: CellerateRX Surgical Hydrolyzed Collagen 5g Type I bovine collagen for chronic and acute wounds, partial and full thickness wounds, pressure injuries I-IV, venous stasis ulcers, arterial ulcers, diabetic ulcers, traumatic wounds, first and second degree burns, superficial wounds and surgical wounds. Sterile until opened. Store at room temperature. For use on moderately to heavily exudative wounds. Cleanse the wound per facility protocol. Apply CellerateRX Powder over the entire wound bed and the edges of the wound. Cover with an appropriate dressing. Reapply 2-3 times a week, or with each dressing change, taking care not to disrupt wound site. https://sanaramedtech.com/surgical/celleraterx-surgical/ FDA UDI

Identifiers

Primary DI / UDI-DI: 00850019972085 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 Surgical by Applied Nutritionals — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Animal-derived wound matrix dressing.

PuraPly™ Antimicrobial XT Wound Matrix — ORGANOGENESIS INC. · Class I
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: Applied Nutritionals

Sources (1)

FDA UDI 9989a883-aba1-40ec-b268-e711bd32b9fb 35 fields · synced May 30, 2026