Catalog Number

EG-BP

Brand Name

Endogel

Version/Model Number

EG-BP

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

Product Code

KJJ

Product Code Name

Cleanser, Root Canal

Public Device Record Key

8225896d-4aad-4d51-8f0c-557f7e5e8398

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-