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Trivex System

FDA UDI

Class II (US FDA UDI)

by LeMaitre Vascular, Inc.

Identity

Trade Name
Trivex System FDA UDI
Generic Name
Transillumination phlebectomy system FDA UDI
Device Name
Trivex System cart FDA UDI
Model / Reference
7210414 FDA UDI
Description
Trivex System cart FDA UDI

Identifiers

Catalog Number
7210414 FDA UDI
Primary DI / UDI-DI
00840663106547 FDA UDI
510(k) Number
K032387 FDA UDI
FDA Product Code
DWQ FDA UDI
GMDN Term
Transillumination phlebectomy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4885 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transillumination phlebectomy system

Trivex System by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transillumination phlebectomy system.

Cleared under the same submission

K032387 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA UDI 3318b943-2348-46c6-9b70-83496d5cbca7 36 fields · synced Jun 9, 2026