Tronex International, Inc.

Basic Information

• Brand Name: Tronex International, Inc.
• Primary DI: 10097604424490
• Version / Model: TCB4244N
• Company Name: TRONEX INTERNATIONAL, INC.
• Labeler DUNS: 615425519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 108
• Record Status: Published
• Publish Date: 2024-12-30
• Public Version: 2
• Public Version Date: 2025-02-14
• Public Version Status: Update
• Public Device Record Key: e1634dec-7826-4c64-b43b-093be070fa1f

Device Description

Cohesive Bandage, Sterile, Latex-Free, Natural, 4" x 5 yds

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: Yes
• 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
48127	Woven gauze roll/sheet	A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and injury padding and compression. It is not a dedicated pressure dressing and does not include latex. 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	00097604424493	GS1
Primary	10097604424490	GS1

Customer Contacts

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