Catalog Number

C402-0C

Brand Name

Catachem DiscretPak™

Version/Model Number

C402-0C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2018

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062503

Product Code

KWW

Product Code Name

Radioimmunoassay, Cholyglycine, Bile Acids

Public Device Record Key

f457ef9d-307d-417f-9b35-9cbc259de5cd

Public Version Date

November 30, 2018

Public Version Number

4

DI Record Publish Date

November 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-