Catalog Number

9518918

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9518918

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

EKQ

Product Code Name

PREPARER, ROOT CANAL ENDODONTIC

Public Device Record Key

db03a1fd-b21d-496b-998d-f5764350d105

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-