Trivex System 7210387

GUDID 00840663106561

TRIVEX System Resector handpiece

LEMAITRE VASCULAR, INC.

Transillumination phlebectomy system

• Primary Device ID: 00840663106561
• NIH Device Record Key: 48c8ddd5-e6f0-4c16-ba03-d99edb338026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trivex System
• Version Model Number: 7210387
• Catalog Number: 7210387
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com
• Phone: 781-221-2266
• Email: csus@lemaitre.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663106561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032387

FDA Product Code

• DWQ: Stripper, Vein, External

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

[00840663106561]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-15

On-Brand Devices [Trivex System]

• 00840663107391: TRIVEX System Resector handpiece, refurbished
• 00840663106738: Trivex System Replacement Lamp
• 00840663106646: Autoclavable Storage and Sterilization Tray (20”x9”x2”)
• 00840663106639: TRIVEX System Illuminator Tubing
• 00840663106622: 5.5mm TRIVEX System Resector Kit (blade and tubing)
• 00840663106615: 4.5mm TRIVEX System Resector Kit (blade and tubing)
• 00840663106608: VERSITIP, ACMI adaptor for instrument end
• 00840663106592: VERSITIP, TRIVEX adaptor for control unit end
• 00840663106585: GEMINI Universal Light guide, 4mm x 10ft
• 00840663106578: TRIVEX System Illuminator
• 00840663106561: TRIVEX System Resector handpiece
• 00840663106554: TRIVEX System footswitch
• 00840663106547: Trivex System cart
• 00840663106530: Trivex System control unit with build in pump
• 00840663106523: Trivex System