Catalog Number

SOP11ATSSC

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP11ATSSC

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

285cc949-4990-4396-831a-dd63dbc62e5c

Public Version Date

July 23, 2018

Public Version Number

2

DI Record Publish Date

June 05, 2018

Package DI Number

50887488997740

Quantity per Package

2

Contains DI Package

10887488997742

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE