Catalog Number

AOW

Brand Name

AuraOpaquer

Version/Model Number

1.2 mL White

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

36d53b36-b4f0-44da-98a1-9b73996307dc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 05, 2016

Package DI Number

D820AOW1

Quantity per Package

2

Contains DI Package

D820AOW0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-