Catalog Number

-

Brand Name

JETi

Version/Model Number

WVSDUP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K201998

Product Code

QEZ

Product Code Name

Aspiration Thrombectomy Catheter

Public Device Record Key

c5faf3d1-8e23-4a21-aeb1-a2e7beaa35ba

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

December 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-