FDA.reportPublic FDA data

Dakin's Wound Cleanser 16oz w/ Septum Cap

Primary DI
00304365212840
Brand
Dakin's Wound Cleanser 16oz w/ Septum Cap
Company
Century Pharmaceuticals Inc
Model
1
Device description
Dakin's Wound Cleanser 16oz w/ Septum Cap
Published
2023-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00304365212840PackageGS18In Commercial Distribution
00304365201653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304365212840003043652128403043652128400304365212840
00304365201653003043652016533043652016530304365201653

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042815464
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00304365312847Dakin's Wound Cleanser Pro 16oz w/ Septum Cap12023-05-16
00304365300813Dakin's Wound Cleanser Pro 8oz w/ Cap12022-09-20
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

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