Catalog Number

294020

Brand Name

Kitazato ET Catheter Type5-v2 EC-PRO Stylet

Version/Model Number

294020 Type5-2 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

ea8818ea-dc06-4870-82d5-9a7d8bf813cd

Public Version Date

March 29, 2021

Public Version Number

2

DI Record Publish Date

February 07, 2019

Package DI Number

14580303269791

Quantity per Package

10

Contains DI Package

04580303269794

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-