FDA.reportPublic FDA data

BIAKOS™ Antimicrobial Wound Gel

Primary DI
10860000939598
Brand
BIAKOS™ Antimicrobial Wound Gel
Company
Sanara Medtech Inc.
Model
AWG0101-12
Device description
BIAKOS™ Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB.
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192527000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192527000Rochal Antimicrobial Wound GelRochal Industries, LLC2020-02-07FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000939598PrimaryGS10
00860000939591Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000093959810860000939598
00860000939591008600009395918600009395910860000939591

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
800-205-7719customerservice@sanaramedtech.com

Regulatory Flags#

DUNS number
807043914
Device count
12
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017274105CellerateRX SurgicalWCI-02-SACRXP2025-12-03
00850017274075CellerateRX SurgicalWCI-05-SACRXP2024-05-23
00850017274082CellerateRX SurgicalWCI-01-SACRXP2024-05-23
00850017274006BIASURGE™ Advanced Surgical SolutionBAS-01012023-10-26
00860000939553BIAKOS™ Antimicrobial Skin & Wound CleanserAWC08102023-06-20
00850017274099 CellerateRX® Hydrolyzed Collagen Gel 28 gramsCRXG-28GMEA2025-07-17
00860000939508Hycol®HCP01102024-10-31
00860000939591BIAKOS™ Antimicrobial Wound GelAWG0101-122025-02-26
00860000939539BIAKOS™ Antimicrobial Skin & Wound CleanserAWC04012023-08-17
20860000939557BIAKOS™ Antimicrobial Skin & Wound CleanserAWC08102023-06-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
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10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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