Catalog Number

-

Brand Name

JETi All In One Sterile Kit - 8Fr

Version/Model Number

WV8803A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 26, 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

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

31f629d3-5c2f-4427-82a1-cd6483ef19fe

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

September 10, 2021

Package DI Number

B139WV8803A2

Quantity per Package

1

Contains DI Package

B139WV8803A1

Package Discontinue Date

October 08, 2021

Package Status

Not in Commercial Distribution

Package Type

Corrugated Box