Catalog Number

0317

Brand Name

Urine Control

Version/Model Number

0317

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

-

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

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

4bf17912-fb83-4dbf-8622-151b7e363984

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Package DI Number

04250317526007

Quantity per Package

5

Contains DI Package

04250317546500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-