Catalog Number

851-921

Brand Name

BlueRay3

Version/Model Number

851-921

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 17, 2018

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

K032465

Product Code

EBZ

Product Code Name

ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Public Device Record Key

d3284a8e-7f85-4737-aa12-14083b4af214

Public Version Date

June 22, 2020

Public Version Number

5

DI Record Publish Date

November 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-