Catalog Number

-

Brand Name

JETi Accessory Cart Attachment Kit

Version/Model Number

WV0016

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2022

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

61f17667-b42a-426f-83c2-93651d1d6d1e

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

June 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-