Catalog Number

SENCGNESH1

Brand Name

CARDINAL HEALTH

Version/Model Number

SENCGNESH1

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

3e009bb0-b3d6-4559-822e-171781225114

Public Version Date

February 14, 2020

Public Version Number

1

DI Record Publish Date

February 06, 2020

Package DI Number

50888439705414

Quantity per Package

2

Contains DI Package

10888439705416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE