Protexer

Basic Information

• Brand Name: Protexer
• Primary DI: 00813360021789
• Version / Model: ICP-SCNS
• Catalog Number: ICP-SCNS0003
• Company Name: ICP MEDICAL, LLC
• Labeler DUNS: 078780963
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-19
• Public Version: 1
• Public Version Date: 2025-08-27
• Public Version Status: New
• Public Device Record Key: 8e8ccb82-7ce5-4c80-a351-d1f6b0b92f32

Device Description

Fluid Resistant Shoe Cover, Traction Coating, Universal

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: Yes
• 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
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15056	Shoe cover	A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813360021786	GS1	Bag	100	In Commercial Distribution
Primary	00813360021789	GS1
Package	20813360021783	GS1	Case	2	In Commercial Distribution