Catalog Number

750-16

Brand Name

Endo-CHX

Version/Model Number

750-16

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

-

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

K070401

Product Code

KJJ

Product Code Name

CLEANSER, ROOT CANAL

Public Device Record Key

5b79a34e-d637-4a5c-b4c3-86962cdd7929

Public Version Date

May 06, 2020

Public Version Number

5

DI Record Publish Date

July 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-