Catalog Number

-

Brand Name

UCARE 11 Stick

Version/Model Number

P412

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K952307

Product Code

CDM

Product Code Name

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Public Device Record Key

a16caa3f-e1cb-4023-be6e-20a780a72f7d

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

July 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-