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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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WaveLight - 00380659984372

Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye.
Alcon Laboratories, Inc.
1023
In Commercial Distribution

  • 00380659984372 ()
8065998437

  • Eye anterior segment analyser

WaveLight - 00380659909634

WL ANALYZER II-USA
Alcon Laboratories, Inc.
8065990963
Not in Commercial Distribution

  • 00380659909634 ()


  • Automated ophthalmic refractometer

ACRYSOF® IQ RESTOR® - 00380659909481

AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software

ACRYSOF, IQ RESTOR - 00380659909474

AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software

WAVELIGHT REFRACTIVE SUITE - 00380659908965

STAND ALONE PATIENT BED
Alcon Laboratories, Inc.
8065990896
In Commercial Distribution

  • 00380659908965 ()

  • Weight: 1078 Pound
8065990896

  • Ophthalmic chair, line-powered

WAVENET - 00380659908170

ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution

  • 00380659908170 ()
8065990817

  • Laser application software

WAVELIGHT EX500 EXCIMER LASER - 00380659907944

WAVELIGHT EX500 EX LASER US
Alcon Laboratories, Inc.
8065990794
In Commercial Distribution

  • 00380659907944 ()

  • Weight: 1200 Pound
8065990794

  • Ophthalmic excimer laser system

WAVELIGHT ALLEGRO TOPOLYZER - 00380659907678

WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990767
In Commercial Distribution

  • 00380659907678 ()

  • Weight: 70.4 Pound


  • Corneal topography system

WAVELIGHT REFRACTIVE SUITE - 00380659907463

REFRACTIVE SUITE SWIVEL BED
Alcon Laboratories, Inc.
8065990746
Not in Commercial Distribution

  • 00380659907463 ()

  • Weight: 800 Pound


  • Ophthalmic chair, line-powered

PERFLUORON - 00380659001642

PFNO KIT 7ML<USA Kit Contents: One 7 mL vial of sterile PERFLUORON Liquid One 10 mL syringe One 20 gauge beveled needle One 0.2 micron filter unit One 23 gauge blunt cannula One PERFLUORON Liquid package insert
Alcon Laboratories, Inc.
0090010016
In Commercial Distribution

  • 00380659001642 ()
  • 10380659001649 ()

  • Total Volume: 7 Milliliter
8065900164

  • Aqueous/vitreous humour replacement medium kit
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