AccessGUDID - DEVICE: Eze-Sit Valvulotome (00840663102297)

GUDID

Device Identifier (DI) Information

Brand Name: Eze-Sit Valvulotome
Version or Model: 94cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TIVK2030
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663102297
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: Eze-Sit Valvulotome Overall product length- 94cm Usable/ effective length- 91cm

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
62527	Valvulotome, percutaneous	A sterile, flexible tube with an exposable blade assembly at its distal end designed to incise/excise peripheral venous valves to allow retrograde flow of blood. It is introduced percutaneously over an in-situ guidewire into a vein before being advanced distally to the valves, where the cutting implement is exposed using controls at the proximal end. This is a single-use device.	Active	false
14339	Valvulotome	A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGZ	Valvulotome

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: Yes
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
Shaft Length: 94 Centimeter

Device Record Status

Public Device Record Key: f99edcc0-b09b-4679-bd58-35b2c1deef3c
Public Version Date: November 27, 2024
Public Version Number: 2
DI Record Publish Date: June 30, 2022