Catalog Number

TMI1197

Brand Name

NA

Version/Model Number

Shapeable IUI Catheter, 23cm

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"

Yes

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

1b3d1268-106c-4910-848b-7a0920f96c13

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

10852073002972

Quantity per Package

25

Contains DI Package

00852073002975

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

25