Catalog Number

SENCGPDNO1

Brand Name

CARDINAL HEALTH

Version/Model Number

SENCGPDNO1

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

5c29f8d1-ac03-45ae-885a-e611e877128f

Public Version Date

January 21, 2021

Public Version Number

1

DI Record Publish Date

January 13, 2021

Package DI Number

50888439975763

Quantity per Package

4

Contains DI Package

10888439975765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE