ORA System® VerifEye™

GUDID 00380657530007

ORA System with VerifEyeTM Lynk, Aberrometer 190.5

Alcon Laboratories, Inc.

Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Ophthalmic refractometer, automated Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer
Primary Device ID00380657530007
NIH Device Record Keyd2338f72-d753-4ca6-a468-cb3bb8475a1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameORA System® VerifEye™
Version Model Number8065753000
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100380657530007 [Primary]

FDA Product Code

NCFAberrometer, ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

On-Brand Devices [ORA System® VerifEye™]

00380659983283ORA System with VerifEyeTM+, Aberometer 190.5
00380657530939ORA System with VerifEyeTM+ 2.0, Cart
00380657530038ORA System with VerifEyeTM Lynk, Cart
00380657530014ORA System with VerifEyeTM Lynk, Aberrometer 195.5
00380657530007ORA System with VerifEyeTM Lynk, Aberrometer 190.5
00380657529995ORA System with VerifEyeTM Lynk, Aberrometer 184.5

Trademark Results [ORA System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORA SYSTEM
ORA SYSTEM
85419445 4262249 Live/Registered
ALCON RESEARCH, LLC
2011-09-09

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