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 ID: 00190746007903
• NIH Device Record Key: a295cdac-689e-4f98-b67e-4b1bfb889483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlueRay3
• Version Model Number: 851-940
• Catalog Number: 851-940
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-7687
• Email: info@americanortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746007903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032465

FDA Product Code

• EBZ: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-24

On-Brand Devices [BlueRay3]

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