FDA.reportPublic FDA data

Trivex System

Primary DI
00840663107391
Brand
Trivex System
Company
Lemaitre Vascular, Inc.
Model
7210387F
Catalog number
7210387F
Device description
TRIVEX System Resector handpiece, refurbished
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
00840663107391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663107391008406631073918406631073910840663107391

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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18
00840663110377AlboGraft Polyester Vascular Graft ATC6038ATC60382021-06-18
00840663110384AlboGraft Polyester Vascular Graft ATC1206ATC12062021-06-18
00840663102815AlboGraft Polyester Vascular GraftAMC1506AMC15062015-07-30
00840663102839AlboGraft Polyester Vascular Graft AMC4006AMC40062015-10-16
00840663102846AlboGraft Polyester Vascular GraftAMC6006AMC60062015-10-16
00840663102853AlboGraft Polyester Vascular GraftAMC1006AMC10062015-10-16
00840663102860AlboGraft Polyester Vascular GraftAMC4007AMC40072015-10-16
00840663102877AlboGraft Polyester Vascular GraftAMC1508AMC15082015-10-16
00840663102884AlboGraft Polyester Vascular GraftAMC3008AMC30082015-10-16
00840663102891AlboGraft Polyester Vascular Graft AMC4008AMC40082015-10-16
00840663102907AlboGraft Polyester Vascular Graft AMC6007AMC60072015-10-16
00840663102914AlboGraft Polyester Vascular Graft AMC6008AMC60082015-10-16
00840663102921AlboGraft Polyester Vascular Graft AMC1008AMC10082015-10-16
00840663102938AlboGraft Polyester Vascular Graft AMC1510AMC15102015-10-16
00840663102945AlboGraft Polyester Vascular Graft AMC3010AMC30102015-10-16
00840663102952AlboGraft Polyester Vascular Graft AMC4010AMC40102015-10-16
00840663102969AlboGraft Polyester Vascular Graft AMC6010AMC60102015-10-16
00840663102976AlboGraft Polyester Vascular Graft AMC1010AMC10102015-10-16
00840663102983AlboGraft Polyester Vascular Graft AMC1512AMC15122015-10-16

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
00840663106608Trivex 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