Catalog Number

SOP12TJ55H

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP12TJ55H

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

ebdf57a0-afa2-420c-87d5-e0c8f9b32199

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

50888439874240

Quantity per Package

1

Contains DI Package

10888439874242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE