Catalog Number

863601

Brand Name

EndoEssentials™ Gutta Percha Points F1 - EE PT Series

Version/Model Number

863601

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKM

Product Code Name

GUTTA-PERCHA

Public Device Record Key

4096542a-a83d-4867-9adb-d26ea0ca85f0

Public Version Date

March 25, 2020

Public Version Number

1

DI Record Publish Date

March 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-