Trivex System

Basic Information

• Brand Name: Trivex System
• Primary DI: 00840663106578
• Version / Model: 7210351
• Catalog Number: 7210351
• Company Name: Lemaitre Vascular, Inc.
• Labeler DUNS: 184805166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-15
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 5141dfaa-6d62-4d7d-98ec-cd37a9e9499d

Device Description

TRIVEX System Illuminator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWQ	Stripper, Vein, External	Cardiovascular	870.4885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32252	Transillumination phlebectomy system illuminator	A hand-operated surgical instrument, a component of a transillumination phlebectomy system used for the resection and ablation of varicose veins, intended to supplycold light for the percutaneous illumination and visualization of a phlebectomy operative site. It typically consists of a tubular stainless steel sheath in which a fibreoptic bundle conducts the light from a light source, via a connected fibreoptic cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663106578	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032387	000