Catalog Number

-

Brand Name

MTG Cath-Lean®

Version/Model Number

42414

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

124afad6-7ef7-492e-a021-bbc4b945528b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

10892673002477

Quantity per Package

100

Contains DI Package

00892673002470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-