NON-STERILE WIPERS

Basic Information

• Brand Name: NON-STERILE WIPERS
• Primary DI: 00843356102482
• Version / Model: PW0909100
• Company Name: CYGNUS MEDICAL L.L.C.
• Labeler DUNS: 103169095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2023-04-07
• Public Version Status: Update
• Public Device Record Key: d9d9ca67-1eba-4373-ad78-b0c18a2f8d9a

Device Description

9" X 9" NON-STERILE BULK PACKED, POLYESTER LASER SEALED EDGE 140 GRAM WIPERS - 100 wipers PER BAG

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58077	Medical device cleaning/disinfection wipe	A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10843356102489	GS1		6	In Commercial Distribution
Primary	00843356102482	GS1
Unit of Use	30843356102483	GS1