Anasept Antimicrobial Skin and Wound Gel

FDA UDI

Class U (US FDA UDI)

by Anacapa Technologies, Inc.

Identity

Trade Name: Anasept Antimicrobial Skin and Wound Gel FDA UDI
Generic Name: Wound hydrogel dressing, antimicrobial FDA UDI
Device Name: Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® Gel inhibits the growth of microorganisms, such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris. FDA UDI
Model / Reference: 5015G FDA UDI
Description: Anasept® Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel that helps maintain moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering 0.057% broad spectrum antimicrobial sodium hypochlorite. Anasept® Gel inhibits the growth of microorganisms, such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Acinetobacter baumannii, Clostridium difficile and antibiotic resistant strains such as Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Carbapenem resistant E.coli (CRE) that are commonly found in wound bed as well as fungi such as Aspergillus niger, Candida albicans and Candida auris. FDA UDI

Identifiers

Catalog Number: 5015G FDA UDI
Primary DI / UDI-DI: 00367180500158 FDA UDI
510(k) Number: K073547 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound hydrogel dressing, antimicrobial FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

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: Weight — 43 Gram FDA UDI

Category: Wound hydrogel dressing, antimicrobial

Anasept Antimicrobial Skin and Wound Gel by Anacapa Technologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound hydrogel dressing, antimicrobial.

Pure&Clean — Pure & Clean, LLC · U
EltaMD SilverGel 1.5 oz — CP Skin Health Group, Inc. · U
BlastX™ — Next Science LLC · U
ProCure — Twin Med, LLC · U
Armor Gel — Abl Medical, LLC · U
L-Mesitran Hydro — Theo Manufacturing B.V. · U
Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC · U
Carestat — American Biotech Labs · U

Cleared under the same submission

K073547 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: Anacapa Technologies, Inc.

Sources (1)

FDA UDI c4049830-fca4-406f-8a62-18ee6e1a1080 38 fields · synced May 30, 2026