Catalog Number

9520854

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9520854

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

EHM

Product Code Name

STRIP, POLISHING AGENT

Public Device Record Key

be91e5e4-cebf-4d2f-a768-5d2ea1ab7ce9

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-