FDA.reportPublic FDA data

BIASURGE™ Advanced Surgical Solution

Primary DI
00850017274006
Brand
BIASURGE™ Advanced Surgical Solution
Company
Sanara Medtech Inc.
Model
BAS-0101
Device description
BIASURGE Advanced Surgical Solution is a clear, colorless solution for use with lavage or preferred application method. The product contains PHMB as a preservative to reduce microbial growth within the packaging during shelf storage after the sterile seal has been broken.
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K223377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223377000BIASURGE Advanced Surgical SolutionRochal Technologies, LLC2023-03-30FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017274003PackageGS16Not in Commercial Distribution
00850017274006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001727400310850017274003
00850017274006008500172740068500172740060850017274006

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
807043914
Device count
1
Combination product
true
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
00860000939553BIAKOS™ Antimicrobial Skin & Wound CleanserAWC08102023-06-20
00850017274099 CellerateRX® Hydrolyzed Collagen Gel 28 gramsCRXG-28GMEA2025-07-17
00860000939508Hycol®HCP01102024-10-31
10860000939598BIAKOS™ Antimicrobial Wound GelAWG0101-122025-02-26
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
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
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00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
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00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
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00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06