FDA.reportPublic FDA data

Dimora

Primary DI
06942327050044
Brand
Dimora
Company
Winner Medical Co., Ltd.
Model
603-019301
Device description
Skin and Wound Cleanser
Published
2026-03-30
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16942327050041PackageGS11In Commercial Distribution
26942327050048PackageGS130In Commercial Distribution
06942327050044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694232705004116942327050041
2694232705004826942327050048
06942327050044069423270500446942327050044

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.

Regulatory Flags#

DUNS number
530629351
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16941094086369Dimora603-0129792026-03-30
16942327002804Winner603-0164052026-03-30
16942327004853Dimora603-0191732026-03-30
16942327019628Dimora603-0191712026-03-30
16942327023243Dimora603-0191812026-03-30
16942327050027Dimora603-0191692026-03-30
16942327068305Dimora603-0192392026-03-30
26942327065882Winner604-0153632026-03-30
06942327001107Niceful603-0191892026-03-30
06942327037908Niceful603-0191902026-03-30
06942327072916Dimora603-0191752026-03-30
16941094085911Dimora603-0129782026-03-27
16941094023227winner medical604-0073302020-06-17
16941094023838winner medical604-0073552020-07-23
16941094064145Dimora603-0129792022-12-01
16941094064183Dimora603-0129782022-12-01
06941094021851winner medical604-0069282020-06-24
16941094064015winner604-0068732022-05-24
16941094025016winner604-0074152022-05-16
16941094036166winner604-0079652022-05-16

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Primary DI, Brand, Company table
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00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
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05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29