Catalog Number

EARD22

Brand Name

EndoActivator

Version/Model Number

EARD22

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

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

EIC

Product Code Name

SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Public Device Record Key

01eef032-097d-4044-991d-d02d258b7ab5

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-