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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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ClearCut®; Intrepid - 00380659920455

ClearCut® Slit Knife Intrepid micro-coaxial system 2.0 SB
Alcon Laboratories, Inc.
8065992045
In Commercial Distribution

  • 10380659920452 ()
  • 00380659920455 ()


  • Ophthalmic knife, single-use

ClearCut®; Intrepid - 00380659918452

ClearCut® Slit Knife Intrepid micro-coaxial system 1.8 SB
Alcon Laboratories, Inc.
8065991845
In Commercial Distribution

  • 10380659918459 ()
  • 00380659918452 ()


  • Ophthalmic knife, single-use

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 - 00380659909412

WAVELIGHT FS200
Alcon Laboratories, Inc.
8065990941
In Commercial Distribution

  • 00380659909412 ()


  • Femtosecond ophthalmic solid-state laser system

WAVELIGHT REFRACTIVE SUITE - 00380659908965

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

  • 00380659908965 ()

  • Weight: 1078 Pound
8065990896

  • Ophthalmic chair, line-powered

WaveLight - 00380659908194

Wavelight FS200 Patient intereface
Alcon Laboratories, Inc.
8065990819
Not in Commercial Distribution

  • 10380659908191 ()
  • 00380659908194 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use

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
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