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
00850073677032Shur-Clens9801032026-02-17
00850073677056Skin-Clens9801052026-02-17
00850073677063Skin-Clens9801052026-02-17
10850073677008Shur-Clens9800992025-04-30
20850073677005Shur-Clens9800992025-04-30
10860006476035Shur-Clens9800932025-04-23
00860006476038Shur-Clens9800932025-04-23
10850073677015Shur-Clens9801012025-04-16
10860006476028Shur-Clens9800982025-04-16
10860006476042Shur-Clens9800962025-04-16
10860006476059Shur-Clens9800972025-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
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07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
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