FDA.reportPublic FDA data

Dakin's Wound Cleanser Pro 8oz w/ Cap

Primary DI
00304365300813
Brand
Dakin's Wound Cleanser Pro 8oz w/ Cap
Company
Century Pharmaceuticals Inc
Model
1
Device description
Dakin's Wound Cleanser Pro 8oz w/ Cap
Published
2022-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K090791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090791000DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%Century Pharmaceuticals, Inc.2009-08-07FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304365306440PackageGS18In Commercial Distribution
00304365300813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304365306440003043653064403043653064400304365306440
00304365300813003043653008133043653008130304365300813

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, multiple soluteA solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
317-849-4210info@dakins.net

Regulatory Flags#

DUNS number
042815464
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304361008089WoundClenz 8 oz w/ sprayer12022-09-20
00304369600421Moi-stir 4 oz w/ sprayer1MOI-04-SPR2024-02-14
00304365200816Dakin's Wound Cleanser 8 oz w/ capN/ADWC-08-CAP2023-07-25
00304365201653Dakin's Wound Cleanser 16oz w/ Septum Cap12023-05-16
00304365301650Dakin's Wound Cleanser Pro 16oz w/ Septum Cap12023-05-16
00304365212840Dakin's Wound Cleanser 16oz w/ Septum Cap12023-05-16
00304365312847Dakin's Wound Cleanser Pro 16oz w/ Septum Cap12023-05-16
00304365200823Dakin's Wound Cleanser 8oz w/ sprayer12022-09-20
00304365201615Dakin's Wound Cleanser 16oz w/ cap12022-09-20
00304365300820Dakin's Wound Cleanser Pro 8oz w/ sprayer12022-09-20
00304365301612Dakin's Wound Cleanser Pro 16oz w/ cap12022-09-20
00304361006436WoundClenz 8 oz w/ sprayer12022-09-20
00304365306440Dakin's Wound Cleanser Pro 8oz w/ Cap12022-09-20
00355299601040Moi-stir 4 oz12022-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
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
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06