FDA.reportPublic FDA data

Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing

Primary DI
00856040008762
Brand
Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing
Company
ARGENTUM MEDICAL, LLC
Model
5015G
Device description
Anasept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing cap
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

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
K073547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073547000ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GELAnacapa Technologies, Inc.2008-04-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856040008786PackageGS112In Commercial Distribution
00856040008762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856040008786008560400087868560400087860856040008786
00856040008762008560400087628560400087620856040008762

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.

Regulatory Flags#

DUNS number
091449079
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857278000009Silverlon Antimicrobial Wound DressingIVCD-15-852020-09-30
00653599000250CathGrip511002020-01-07
00653599000274CathGrip51250BOM51250BX2020-01-07
00653599000298CathGrip51250NSBOM51250NSBX2020-01-08
00653599000311CathGrip51250NSNA2020-01-08
00653599000328CathGrip51250NSNW2020-01-16
00653599000342CathGrip51250SFPNA2021-05-12
00653599000366CathGrip51300BOM51300BX2020-01-07
00653599000373CathGrip51300NSBOM51300NSBX2020-01-08
00653599000380CathGrip51300NSNA2020-01-09
00653599000397CathGrip51300SFP2020-01-16
00653599000403CathGrip51300SFPNA2020-01-16
00653599000410CathGrip51301BOM51301BX2020-01-07
00653599000434CathGrip51301NSBOM51301NSBX2020-01-08
00653599000458CathGrip51301NSNA2020-01-16
00653599000489CathGrip51301SFP2020-01-16
00653599000496CathGrip51301SFPNA2020-07-07
00653599000519CathGrip513032020-01-07
00653599000526CathGrip51350BOM51350BX2020-01-07
00653599000533CathGrip51350NSBOM51350NSBX2020-01-08

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