Catalog Number

9509574

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9509574

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

-

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

EKE

Product Code Name

CURETTE, OPERATIVE

Public Device Record Key

8c33dff7-dc47-4233-a86e-a600b1cc67f3

Public Version Date

June 03, 2020

Public Version Number

1

DI Record Publish Date

May 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-