Catalog Number

-

Brand Name

JETi Saline Drive Unit

Version/Model Number

WV0345

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 03, 2021

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

-

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

QEZ

Product Code Name

Aspiration Thrombectomy Catheter

Public Device Record Key

88f84b31-516a-40fa-9c68-22d9f4fa66b7

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

June 17, 2019

Package DI Number

B139WV03451

Quantity per Package

1

Contains DI Package

B139WV03450

Package Discontinue Date

June 03, 2021

Package Status

Not in Commercial Distribution

Package Type

Case