Catalog Number

SEN44OPSC3

Brand Name

CARDINAL HEALTH

Version/Model Number

SEN44OPSC3

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

OFX

Product Code Name

General purpose dental tray

Public Device Record Key

4d5fd69b-2138-494d-ab33-07c382163edd

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

Package DI Number

50888439662427

Quantity per Package

4

Contains DI Package

10888439662429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE