Catalog Number

-

Brand Name

MTG Instant Cath® Mini-Pak

Version/Model Number

12116

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)

Yes

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

a0169141-3bea-46b4-8ca8-771453dff9e2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

10892673002811

Quantity per Package

100

Contains DI Package

00892673002814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-