Critical Cover

Basic Information

• Brand Name: Critical Cover
• Primary DI: 10817583023046
• Version / Model: MS-01J06-8
• Catalog Number: MS-01J06-8
• Company Name: ALPHA PRO TECH INC
• Labeler DUNS: 003687733
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2020-12-18
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: 09313821-e161-44cc-8c88-1d56f5a84556

Device Description

Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV

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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61939	Surgical sleeve cover	A forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817583023043	GS1	Case	1	In Commercial Distribution
Primary	10817583023046	GS1
Unit of Use	00817583023049	GS1

Customer Contacts

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