Catalog Number

J-IUIC-351351

Brand Name

Insemi-Cath

Version/Model Number

G17343

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

MFD

Product Code Name

CANNULA, INTRAUTERINE INSEMINATION

Public Device Record Key

7c1ad2fe-3a2a-4cae-b17d-b818f03382ae

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10827002173436

Quantity per Package

20

Contains DI Package

00827002173439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-