AccessGUDID - DEVICE: JETi Thrombectomy System, Sterile Disposable Components Kit (B139WV60031)

GUDID

Device Identifier (DI) Information

Brand Name: JETi Thrombectomy System, Sterile Disposable Components Kit
Version or Model: WV6003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WALK VASCULAR L.L.C.

Primary DI Number: B139WV60031
Issuing Agency: HIBCC
Commercial Distribution End Date: February 18, 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:	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?
36142	Aspiration tray, single-use	A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 6 French
Catheter Length: 120 Centimeter

Device Record Status

Public Device Record Key: a903032c-61b7-48ca-aea5-e62ede9ba83d
Public Version Date: September 27, 2022
Public Version Number: 3
DI Record Publish Date: February 08, 2019