Catalog Number

SOP45SPAMB

Brand Name

CARDINAL HEALTH

Version/Model Number

SOP45SPAMB

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

eb455040-c102-4952-9d81-78777febd9f3

Public Version Date

August 09, 2018

Public Version Number

2

DI Record Publish Date

July 09, 2018

Package DI Number

50887488999614

Quantity per Package

4

Contains DI Package

10887488999616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE