BIAKOS™ Antimicrobial Wound Gel

FDA UDI

Class U (US FDA UDI)

by Sanara Medtech Inc.

Identity

Trade Name: BIAKOS™ Antimicrobial Wound Gel FDA UDI
Generic Name: Wound hydrogel dressing, antimicrobial FDA UDI
Device Name: BIAKOS™ Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. FDA UDI
Model / Reference: AWG0101-12 FDA UDI
Description: BIAKOS™ Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. FDA UDI

Identifiers

Primary DI / UDI-DI: 10860000939598 FDA UDI
510(k) Number: K192527 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

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

Yes

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Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

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Category: Wound hydrogel dressing, antimicrobial

BIAKOS™ Antimicrobial Wound Gel by Sanara Medtech 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
Silver-sept Silver Antimicrobial Skin and Wound Gel — Anacapa Technologies, Inc. · 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

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 4a95b22b-c70c-4ca3-a0c9-8acc4d5ac157 35 fields · synced May 30, 2026