Catalog Number

9520645

Brand Name

Darby Dental Supply, LLC

Version/Model Number

9520645

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBZ

Product Code Name

ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Public Device Record Key

86a3aff3-f684-4231-99a6-4df9a0eba493

Public Version Date

March 21, 2022

Public Version Number

2

DI Record Publish Date

June 07, 2018

Package DI Number

10889813003807

Quantity per Package

12

Contains DI Package

00889813003800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-