Tronex International, Inc.

Basic Information

• Brand Name: Tronex International, Inc.
• Primary DI: 10097604245163
• Version / Model: TCM24510M
• Company Name: TRONEX INTERNATIONAL, INC.
• Labeler DUNS: 615425519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-08-28
• Public Version: 1
• Public Version Date: 2023-09-05
• Public Version Status: New
• Public Device Record Key: 68a0472a-7e14-48f3-8f17-c2cbc8444ef9

Device Description

Scrub, Shirt, Multilayer, No Pockets, V-Neck, Fluid Resistant, Latex-Free, Moroon, Small

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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58382	Scrub suit, single-use	A two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00097604245166	GS1
Primary	10097604245163	GS1

Customer Contacts

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