Catalog Number

SENHFDPSJE

Brand Name

CARDINAL HEALTH

Version/Model Number

SENHFDPSJE

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

6b8892f9-cb6e-4b84-8aa5-149f163fdf41

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Package DI Number

50888439980712

Quantity per Package

5

Contains DI Package

10888439980714

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE