AccessGUDID - DEVICE: TRIVEX (03596010452528)

GUDID

Device Identifier (DI) Information

Brand Name: TRIVEX
Version or Model: 7205946
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7205946
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010452528
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: MTO TRIVEX TM SWEDISH KIT 230-240V

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
42365	Transillumination phlebectomy system control unit	A mains electricity (AC-powered) device that is a component of a transillumination phlebectomy system intended to be used for the resection and ablation of varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is used to supply the power and steering controls for the invasive devices of the system as well as provide the pump for irrigation of the surgical site.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 9728e030-7fc9-4ff2-ad2d-ac55c04e4dce
Public Version Date: September 07, 2023
Public Version Number: 3
DI Record Publish Date: August 23, 2015