Batrik SaveFace Disposable Shoe Covers\Dispenser box

Basic Information

• Brand Name: Batrik SaveFace Disposable Shoe Covers\Dispenser box
• Primary DI: 00690521017047
• Version / Model: SF-SC02XL
• Catalog Number: SF-SC02XL
• Company Name: Batrik Medical Manufacturing Inc
• Labeler DUNS: 243880700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-23
• Public Version: 1
• Public Version Date: 2020-12-31
• Public Version Status: New
• Public Device Record Key: 6988814b-e6e2-4d87-8887-148eb9fea295

Device Description

SaveFace Shoe Covers, anti skid, XL size, Blue

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: Yes
• 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
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13575	Shoe cover, conductive, non-sterile	A non-sterile device made of conductive material designed to reduce the risk of static electricity build-up and intended to be used as a physical barrier on a shoe to prevent cross-contamination between the shoe and the environment. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690521017047	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at ambient temperature & normal humidity