Catalog Number

442750

Brand Name

Synchron

Version/Model Number

442750

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

K060256

Product Code

CDQ

Product Code Name

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Public Device Record Key

b5b96f9f-830a-4bb7-a9cb-ac205bf8f21e

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-