Catalog Number

-

Brand Name

United Urologics Insertion Kit

Version/Model Number

UUIK01

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

02d56bf0-63e7-4f6f-b14f-53023c5ae646

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

March 22, 2017

Package DI Number

10818016020311

Quantity per Package

100

Contains DI Package

00818016020314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-