FDA.reportPublic FDA data

Shur-Clens

Primary DI
10850073677039
Brand
Shur-Clens
Company
Asept Pak, Inc.
Model
980103
Device description
Shur-Clens Wound Therapy Solution - 8 oz. bottle.
Published
2026-02-17
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
FQHLavage, Jet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850073677039PackageGS112In Commercial Distribution
00850073677032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007367703910850073677039
00850073677032008500736770328500736770320850073677032

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-regulated wound irrigation solution applicator, manualA hand-held manual device in the form of a compressible bottle with a specialized nozzle, intended to be used to apply a pressure-regulated jet stream of non-medicated topical solution (e.g., sterile water, saline) to mechanically irrigate, clean/moisten, and decontaminate a wound. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5185612026ghanley@aseptpak.com

Regulatory Flags#

DUNS number
005245137
Device count
1
DM exempt
false
Premarket exempt
true
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
00850073677063Skin-Clens9801052026-02-17
20850073677005Shur-Clens9800992025-04-30
00860006476038Shur-Clens9800932025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50382909101206SurgiphorCAREFUSION 2200, INCFQH2026-03-05
10075450844334Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677063Skin-ClensAsept Pak, Inc.FQH2026-02-17
06970462546825Irrigation PumpShenzhen HugeMed Medical Technical Development Co., Ltd.FQH2026-02-10
15051471214788De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471214795De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217123De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217130De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
00810025928858Caring Mill Saline Wound WashCaring MillFQH2025-07-03
20850073677005Shur-ClensAsept Pak, Inc.FQH2025-04-30
00860006476038Shur-ClensAsept Pak, Inc.FQH2025-04-23
00842351120040Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
ESUM930081200SutterSutter Medizintechnik GmbHFQH2024-06-24
00817278012020Patriot ProMed Michigan Holdings, LLCFQH2024-06-04
05051471211735De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
05051471211742De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720170CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720958PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720965PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721085CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721108CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721122CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11