Tronex International, Inc.

Basic Information

• Brand Name: Tronex International, Inc.
• Primary DI: 10097604493540
• Version / Model: 4935B
• Company Name: TRONEX INTERNATIONAL, INC.
• Labeler DUNS: 615425519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 150
• Record Status: Published
• Publish Date: 2022-10-28
• Public Version: 1
• Public Version Date: 2022-11-07
• Public Version Status: New
• Public Device Record Key: fc0b2f8e-3b22-48ec-98a5-26832dcda042

Device Description

Cover, Shoe, Coated Spunbond, Non-Skid, Ankle-High, Fluid Impervious, Latex-Free, Blue, Extra-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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
Unit of Use	00097604493543	GS1
Primary	10097604493540	GS1