Catalog Number

SOP12MERO3

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP12MERO3

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

d65a23da-2ebf-409a-896a-360cfce00ff8

Public Version Date

January 07, 2022

Public Version Number

1

DI Record Publish Date

December 30, 2021

Package DI Number

50195594491671

Quantity per Package

2

Contains DI Package

10195594491673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE