Catalog Number

-

Brand Name

MTG Soft Intermittent Catheter /Coude W/Indicator Line

Version/Model Number

81712

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

1961785e-25a5-476c-99e4-e3da1132418c

Public Version Date

February 25, 2019

Public Version Number

1

DI Record Publish Date

January 25, 2019

Package DI Number

20851593006481

Quantity per Package

12

Contains DI Package

10851593006484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-