Catalog Number

131182

Brand Name

kitazato IUI Catheter

Version/Model Number

131182 Type4-v2

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

3129894f-f2a8-4377-885b-015bb22bcdb1

Public Version Date

March 29, 2021

Public Version Number

5

DI Record Publish Date

January 25, 2018

Package DI Number

14580303269203

Quantity per Package

50

Contains DI Package

04580303269206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-