Catalog Number

-

Brand Name

United Urologics Closed System Catheter

Version/Model Number

UU12S

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"

Yes

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

-

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

b580c60d-d456-4d66-bbf7-da7298107fd2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 22, 2017

Package DI Number

10818016020113

Quantity per Package

100

Contains DI Package

00818016020116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-