Catalog Number

EG-S

Brand Name

Endogel

Version/Model Number

EG-s

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

K992484,K992484

Product Code

KJJ

Product Code Name

Cleanser, Root Canal

Public Device Record Key

cc73d727-5956-46e1-9992-f4df5dec8ccd

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 08, 2020

Package DI Number

00859611006013

Quantity per Package

24

Contains DI Package

00859611006006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-