Catalog Number

4613

Brand Name

ChlorCid Surf

Version/Model Number

4613

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

-

Product Code

KJJ

Product Code Name

CLEANSER, ROOT CANAL

Public Device Record Key

a911274b-fa86-4933-8e6f-e18ff66b254e

Public Version Date

September 21, 2018

Public Version Number

2

DI Record Publish Date

March 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-