Catalog Number

215023

Brand Name

Kitazato ET Catheter Type1-v2 EC-PRO Normal

Version/Model Number

215023 Type1-v2 EC-PRO Normal

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

K162878,K162878

Product Code

MQF

Product Code Name

CATHETER, ASSISTED REPRODUCTION

Public Device Record Key

95e1e389-abd6-443a-8c64-f2f5e01a45ae

Public Version Date

March 29, 2021

Public Version Number

3

DI Record Publish Date

June 19, 2018

Package DI Number

14580303269470

Quantity per Package

10

Contains DI Package

04580303269473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-