Trivex System

Basic Information

• Brand Name: Trivex System
• Primary DI: 00840663106530
• Version / Model: 7210386
• Catalog Number: 7210386
• 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: 7ac50ffd-ee9a-41be-8c0a-6cfbf0f37935

Device Description

Trivex System control unit with build in pump

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: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
42365	Transillumination phlebectomy system control unit	A mains electricity (AC-powered) device that is a component of a transillumination phlebectomy system intended to be used for the resection and ablation of varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is used to supply the power and steering controls for the invasive devices of the system as well as provide the pump for irrigation of the surgical site.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663106530	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032387	000