BlueRay3 851-940

GUDID 00190746007903

BLUE RAY 3 MINI LED MICROFLASH CURING LIGHT KIT, BRUSHED STAINLESS

AMERICAN ORTHODONTICS CORPORATION

Dental/surgical polymerization lamp
Primary Device ID00190746007903
NIH Device Record Keya295cdac-689e-4f98-b67e-4b1bfb889483
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlueRay3
Version Model Number851-940
Catalog Number851-940
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746007903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-24

On-Brand Devices [BlueRay3]

00190746007910BLUE RAY 3 MINI LED HAND PIECE, BRUSHED STAINLESS
00190746007903BLUE RAY 3 MINI LED MICROFLASH CURING LIGHT KIT, BRUSHED STAINLESS
00190746007897BLUE RAY MINI LED HAND PIECE

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