Catalog Number

999363

Brand Name

D-LISH

Version/Model Number

999363

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"

-

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

EJR

Product Code Name

AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Public Device Record Key

98b065e8-e9ce-43d1-a43f-7a6e53809a9c

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302730001843

Quantity per Package

1

Contains DI Package

00302730001846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Clamshell