Catalog Number

294015

Brand Name

Kitazato ET Catheter Type5-v1 EC-PRO Stylet

Version/Model Number

294015 Type5-v1 EC-PRO Stylet

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

44f7a200-cb3e-4cbe-b793-94061c005e6b

Public Version Date

January 29, 2020

Public Version Number

3

DI Record Publish Date

June 19, 2018

Package DI Number

14580303269784

Quantity per Package

10

Contains DI Package

04580303269787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-