Tronex International, Inc.

Basic Information

• Brand Name: Tronex International, Inc.
• Primary DI: 10097604015568
• Version / Model: TCB0155R
• Company Name: TRONEX INTERNATIONAL, INC.
• Labeler DUNS: 615425519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 432
• Record Status: Published
• Publish Date: 2025-01-28
• Public Version: 1
• Public Version Date: 2025-02-05
• Public Version Status: New
• Public Device Record Key: 783fe3a4-5d54-4114-a9ae-a3ff0eb9fd53

Device Description

Cohesive Bandage, Non-Sterile, Latex-Free, Red

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
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. 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	00097604015561	GS1
Primary	10097604015568	GS1

Customer Contacts

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