Catalog Number

-

Brand Name

URiSCAN 6 L strip

Version/Model Number

U251

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

CEN

Product Code Name

Dye-Indicator, Ph (Urinary, Non-Quant.)

Public Device Record Key

6dd3e45d-c251-428e-a4d9-00860fdc0a8a

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-