Catalog Number

2020359

Brand Name

Henry Schein

Version/Model Number

2020359

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

K112046,K112046

Product Code

KIF

Product Code Name

RESIN, ROOT CANAL FILLING

Public Device Record Key

5c087d35-58af-4300-b3a1-9db8f33a6c96

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10304040016845

Quantity per Package

2

Contains DI Package

00304040016848

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-