Catalog Number

3339436

Brand Name

Henry Schein

Version/Model Number

3339436

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

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

4e437d89-1695-44d8-9717-35d5e033503f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10304040000837

Quantity per Package

18

Contains DI Package

00304040000830

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX