Catalog Number

9004994

Brand Name

Henry Schein

Version/Model Number

9004994

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CDM

Product Code Name

DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Public Device Record Key

e0de83f9-7075-4a32-be42-2c7005634dd0

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10304040002572

Quantity per Package

24

Contains DI Package

00304040002575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-