FDA.reportPublic FDA data

Trivex System

Primary DI
00840663106578
Brand
Trivex System
Company
Lemaitre Vascular, Inc.
Model
7210351
Catalog number
7210351
Device description
TRIVEX System Illuminator
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
00840663106578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663106578008406631065788406631065780840663106578

GMDN Terms#

Term, Definition table
TermDefinition
Transillumination phlebectomy system illuminatorA hand-operated surgical instrument, a component of a transillumination phlebectomy system used for the resection and ablation of varicose veins, intended to supplycold light for the percutaneous illumination and visualization of a phlebectomy operative site. It typically consists of a tubular stainless steel sheath in which a fibreoptic bundle conducts the light from a light source, via a connected fibreoptic cable. This is a reusable device.

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
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
00840663107391Trivex SystemLemaitre Vascular, Inc.DWQ2015-07-15