Catalog Number

SOP21HNEAS

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP21HNEAS

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

e0e9cba4-cd54-4168-b6a6-1a56eeafc156

Public Version Date

March 21, 2019

Public Version Number

1

DI Record Publish Date

March 13, 2019

Package DI Number

50888439317761

Quantity per Package

4

Contains DI Package

10888439317763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE