Catalog Number

-

Brand Name

JETi Thrombectomy System, Sterile Disposable Components Kit

Version/Model Number

WV6003-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 07, 2020

Issuing Agency

In HIBCC

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

825eb94d-de19-4d04-b703-c736723fcf87

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

February 08, 2019

Package DI Number

B139WV600312

Quantity per Package

5

Contains DI Package

B139WV600311

Package Discontinue Date

November 07, 2020

Package Status

Not in Commercial Distribution

Package Type

Corrugated Box