AccessGUDID - DEVICE: Trivex System (00840663106523)

GUDID

Device Identifier (DI) Information

Brand Name: Trivex System
Version or Model: 7210477
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7210477
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663106523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: Trivex System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44305	Transillumination phlebectomy system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWQ	Stripper, Vein, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032387	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56854811-df84-4f5e-b9b5-d7b194a93927
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: July 15, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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