Trivex System 7209515

GUDID 00840663106622

5.5mm TRIVEX System Resector Kit (blade and tubing)

LEMAITRE VASCULAR, INC.

Transillumination phlebectomy system
Primary Device ID00840663106622
NIH Device Record Key4123e15f-f02e-464d-b2de-c3098dff5ed4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrivex System
Version Model Number7209515
Catalog Number7209515
Company DUNS184805166
Company NameLEMAITRE VASCULAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com
Phone781-221-2266
Emailcsus@lemaitre.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840663106622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWQStripper, Vein, External

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-15

On-Brand Devices [Trivex System]

00840663107391TRIVEX System Resector handpiece, refurbished
00840663106738Trivex System Replacement Lamp
00840663106646Autoclavable Storage and Sterilization Tray (20”x9”x2”)
00840663106639TRIVEX System Illuminator Tubing
008406631066225.5mm TRIVEX System Resector Kit (blade and tubing)
008406631066154.5mm TRIVEX System Resector Kit (blade and tubing)
00840663106608VERSITIP, ACMI adaptor for instrument end
00840663106592VERSITIP, TRIVEX adaptor for control unit end
00840663106585GEMINI Universal Light guide, 4mm x 10ft
00840663106578TRIVEX System Illuminator
00840663106561TRIVEX System Resector handpiece
00840663106554TRIVEX System footswitch
00840663106547Trivex System cart
00840663106530Trivex System control unit with build in pump
00840663106523Trivex System

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