Catalog Number

294025

Brand Name

Kitazato ET Catheter

Version/Model Number

294025

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

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

MQF

Product Code Name

CATHETER, ASSISTED REPRODUCTION

Public Device Record Key

8d6e6087-ccea-49e1-81dc-3955d34d8e96

Public Version Date

October 05, 2022

Public Version Number

1

DI Record Publish Date

September 27, 2022

Package DI Number

14580745042310

Quantity per Package

10

Contains DI Package

04580745042313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-