AccessGUDID - DEVICE: JETi All In One Saline Drive Unit (B139WVSDUP0)

GUDID

Device Identifier (DI) Information

Brand Name: JETi All In One Saline Drive Unit
Version or Model: WVSDUP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WALK VASCULAR L.L.C.

Primary DI Number: B139WVSDUP0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 08, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 034774488 *Terms of Use

Device Description: No description.

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?
58214	Mechanical atherectomy/thrombectomy drive system	A multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy and/or thrombectomy catheter (not included) during an intravascular recanalization procedure. It typically consists of an electrically-powered control unit that supplies the drive motor with electricity to power the catheter and a handpiece with hand-switch that includes the drive motor (for catheter manipulation); a foot-switch may also be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEZ	Aspiration Thrombectomy Catheter

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: d767acbf-8903-4ff4-a481-c0f572ca3612
Public Version Date: September 27, 2022
Public Version Number: 3
DI Record Publish Date: February 26, 2021