Shur-Clens

Basic Information

• Brand Name: Shur-Clens
• Primary DI: 00850073677032
• Version / Model: 980103
• Company Name: Asept Pak, Inc.
• Labeler DUNS: 005245137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-17
• Public Version: 1
• Public Version Date: 2026-02-25
• Public Version Status: New
• Public Device Record Key: 6628bc85-0636-4474-aa18-1977e3357089

Device Description

Shur-Clens Wound Therapy Solution - 8 oz. bottle.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQH	Lavage, Jet	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62394	Pressure-regulated wound irrigation solution applicator, manual	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850073677039	GS1	Case	12	In Commercial Distribution
Primary	00850073677032	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius