OPERATING-ROOM SHOE COVER

Basic Information

• Brand Name: OPERATING-ROOM SHOE COVER
• Primary DI: 06950471300076
• Version / Model: 28024
• Company Name: Hangzhou A-Tek Medical & Textiles Co., Ltd.
• Labeler DUNS: 547874292
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-18
• Public Version: 1
• Public Version Date: 2023-07-26
• Public Version Status: New
• Public Device Record Key: c0d1077d-4a54-4e59-ac50-bb8a4fdbd6fb

Device Description

OPERATING-ROOM SHOE COVER, PROTECT WORKSHOES FROM ACCIDENTAL BLOOD OR BODY FLUID SPILLS IN THE OR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
13576	Medical shoe	A footwear designed as a washable shoe available in various forms intended to be worn in pairs in a medical setting. 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06950471300076	GS1