Catalog Number

SOP12SHRO1

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP12SHRO1

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

6f86c4db-b286-4015-a8af-553dfb9a9638

Public Version Date

July 23, 2018

Public Version Number

2

DI Record Publish Date

May 29, 2018

Package DI Number

50887488998259

Quantity per Package

2

Contains DI Package

10887488998251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE