Critical Cover

Basic Information

• Brand Name: Critical Cover
• Primary DI: 10817583021035
• Version / Model: SH-M1316-BH
• Catalog Number: SH-M1316-BH
• Company Name: ALPHA PRO TECH INC
• Labeler DUNS: 003687733
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-07-16
• Public Version: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: f051a0d7-7350-4c3f-82cf-6ac02755a7de

Device Description

Shoe Cover, UltraGrip, BarrierTech Upper, Anti-Skid Sole, Serged Seams, Blue, Large.

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
FXP	Cover, Shoe, Operating-Room	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	20817583021032	GS1	Case	1	In Commercial Distribution
Primary	10817583021035	GS1
Unit of Use	00817583021038	GS1

Customer Contacts

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