Catalog Number

SOT2APPOHD

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT2APPOHD

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

5683c30b-61b8-4b05-988d-65b539b2f6a5

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

April 25, 2022

Package DI Number

50195594491343

Quantity per Package

2

Contains DI Package

10195594491345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE