FDA.reportPublic FDA data

Trivex System

Primary DI
00840663106608
Brand
Trivex System
Company
Lemaitre Vascular, Inc.
Model
2141
Catalog number
2141
Device description
VERSITIP, ACMI adaptor for instrument end
Published
2015-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWQStripper, Vein, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWQStripper, Vein, ExternalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032387000TRIVEX SYSTEMSmith & Nephew, Inc.2003-10-29DWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663106608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663106608008406631066088406631066080840663106608

GMDN Terms#

Term, Definition table
TermDefinition
Transillumination phlebectomy systemAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781-221-2266csus@lemaitre.com

Regulatory Flags#

DUNS number
184805166
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663102297Eze-Sit Valvulotome94cmTIVK20302022-06-30
00840663100095Expandable LeMaitre Valvulotome1000-901000-902015-06-30
00840663100101Expandable LeMaitre Valvulotomee1000-90e1000-902015-06-30
00840663100118Expandable LeMaitre Valvulotome1000-951000-952015-06-30
00840663100132Over-the-Wire LeMaitre Valvulotome1005-001005-002015-06-30
00840663100149Over-the-Wire LeMaitre Valvulotomee1005-00e1005-002015-06-30
00840663100163Over-the-Wire LeMaitre Valvulotome1006-001006-002015-06-30
00840663100309Expandable LeMaitre Valvulotome1096-001096-002015-06-30
00840663106653HYDRO LeMaitre Valvulotome1009-001009-002015-06-30
00840663106660HYDRO LeMaitre Valvulotome1010-001010-002015-06-30
00840663106721Expandable LeMaitre Valvulotomee1096-00e1096-002015-07-15
00840663106820Hydro LeMaitre Valvulotomee1009-00e1009-002015-07-15
00840663106837Hydro LeMaitre Valvulotomee1010-00e1010-002015-07-15
00840663107315Retrograde LeMills Valvulotome1050-001050-002015-06-30
00840663107322Antegrade LeMills Valvulotome1050-011050-012015-06-30
00840663107339Antegrade and Retrograde LeMills Valvulotome1050-021050-022015-06-30
00840663107346Retrograde LeMills Valvulotomee1050-00e1050-002015-06-30
00840663107353Antegrade LeMills Valvulotomee1050-01e1050-012015-06-30
00840663107360Antegrade and Retrograde LeMills Valvulotomee1050-02e1050-022015-06-30
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840663106523Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106530Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106547Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106554Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106561Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106578Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106585Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106592Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106615Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106622Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106639Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106646Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663106738Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15
00840663107391Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15