Catalog Number

-

Brand Name

JETi

Version/Model Number

WVHAND

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

QEZ

Product Code Name

Aspiration Thrombectomy Catheter

Public Device Record Key

86055880-4f74-4df8-ad9e-23cea33b30a0

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

February 26, 2021

Package DI Number

B139WVHAND1

Quantity per Package

1

Contains DI Package

B139WVHAND0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton