Catalog Number

-

Brand Name

MTG Instant Cath® Soft /Coude

Version/Model Number

22716

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

K080878,K080878

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

3e199fff-1fb4-4400-8b8a-12fbe39f7159

Public Version Date

November 09, 2018

Public Version Number

1

DI Record Publish Date

October 09, 2018

Package DI Number

10851593006477

Quantity per Package

100

Contains DI Package

00851593006470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-