Catalog Number

SOP13DFCOC

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP13DFCOC

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

OJH

Product Code Name

Orthopedic tray

Public Device Record Key

4aa0b3c2-063f-4ebd-8119-b325d45451ff

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 30, 2019

Package DI Number

50888439317334

Quantity per Package

4

Contains DI Package

10888439317336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE