Catalog Number

-

Brand Name

MTG Soft Intermittent Catheter, Straight-tip with hydrophilic low-friction coati

Version/Model Number

81214

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

K111405,K111405,K111405

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

34d95486-f38b-4fb0-adc6-3bb27a5e14ff

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

20851593006245

Quantity per Package

12

Contains DI Package

10851593006248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-