Catalog Number

SEN24ETSC3

Brand Name

CARDINAL HEALTH

Version/Model Number

SEN24ETSC3

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

OGR

Product Code Name

Ear, nose, and throat surgical tray

Public Device Record Key

2fb19bf5-ab25-4284-a73b-fe5c1aef08af

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

50195594841094

Quantity per Package

5

Contains DI Package

10195594841096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE