Tronex International, Inc.

Basic Information

• Brand Name: Tronex International, Inc.
• Primary DI: 10097604357521
• Version / Model: 3575B
• Company Name: TRONEX INTERNATIONAL, INC.
• Labeler DUNS: 615425519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• 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: d6a26898-a3a4-4a84-8026-d5165b1eb253

Device Description

Hood, Surgeon, Multilayer, Fluid Resistant, Latex-Free, Blue, Unisize

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
FYF	Cap, Surgical	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32297	Surgical cap, single-use	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. 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	00097604357524	GS1
Primary	10097604357521	GS1

Customer Contacts

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