Catalog Number

71494

Brand Name

Imprint™ 4 Penta™ Heavy

Version/Model Number

71494

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

EFD

Product Code Name

AMALGAMATOR, DENTAL, AC-POWERED

Public Device Record Key

3c80bd10-13b8-4ce6-be97-deeb41181562

Public Version Date

September 22, 2020

Public Version Number

7

DI Record Publish Date

August 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-