Catalog Number

32116

Brand Name

MTG

Version/Model Number

32116

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)

-

Over the Counter (OTC)

Yes

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

88a7863a-b209-48aa-b4cf-4f6fe24151e6

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

50850025153671

Quantity per Package

100

Contains DI Package

00850025153676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case