Catalog Number

20104004

Brand Name

ENGINE REAMERS

Version/Model Number

n008 L21

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EKP

Product Code Name

Reamer, Pulp Canal, Endodontic

Public Device Record Key

444b0f2e-5849-4658-aa38-6fd913777ba0

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Package DI Number

J015201040049

Quantity per Package

10

Contains DI Package

J015201040041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box