Catalog Number

1124868

Brand Name

Henry Schein

Version/Model Number

1124868

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

-

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

7048a68f-0faa-4a78-acfa-6071b071e72a

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10304040002657

Quantity per Package

24

Contains DI Package

00304040002650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-