Catalog Number

9539115

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9539115

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

EKP

Product Code Name

REAMER, PULP CANAL, ENDODONTIC

Public Device Record Key

c119a53d-152b-4fe3-b79b-d63e732b9f91

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-