Catalog Number

100102

Brand Name

Kitazato IUI Catheter with Stainless Steel Center Core Type1-v1

Version/Model Number

100102Type1-v1

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

de68666e-1e80-4076-ab0d-e720fa44cd85

Public Version Date

March 29, 2021

Public Version Number

5

DI Record Publish Date

November 09, 2016

Package DI Number

14580303269050

Quantity per Package

10

Contains DI Package

04580303269053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-