Catalog Number

-

Brand Name

CYBOW 11

Version/Model Number

0A94

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

CDM

Product Code Name

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

Public Device Record Key

84f4bdfc-af62-48dd-b2f0-2c0994b6e54a

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

October 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-