Trivex System

Basic Information

• Brand Name: Trivex System
• Primary DI: 00840663106547
• Version / Model: 7210414
• Catalog Number: 7210414
• 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: 3318b943-2348-46c6-9b70-83496d5cbca7

Device Description

Trivex System cart

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
44305	Transillumination phlebectomy system	An assembly of devices intended to be used for the resection and ablation of varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It typically consists of a mains electricity (AC-powered) control unit that supplies the power and steering for the invasive devices of the system, a pump(s) for irrigation of the surgical site, an illuminator, a resector handpiece, and a foot-switch. Through surgical site illumination, the surgeon performs the procedure under direct visualization (through the transparency of the skin and not blind as in other procedures), typically in an outpatient setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663106547	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032387	000