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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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ORA System® VerifEye™ - 00380659983283

ORA System with VerifEyeTM+, Aberometer 190.5
Alcon Laboratories, Inc.
8065998328
In Commercial Distribution

  • 00380659983283 ()


  • Automated ophthalmic refractometer

LenSx® SoftFit™ - 00380659982767

LenSx® SoftFit™ Patient Interface Flat
Alcon Laboratories, Inc.
8065998276
In Commercial Distribution

  • 00380659982767 ()
  • 20380659982761 ()


  • Ophthalmic laser system eyeball positioning suction cup

LenSx® SoftFit™ - 00380659982750

LenSx® SoftFit™ Patient Interface Steep
Alcon Laboratories, Inc.
8065998275
In Commercial Distribution

  • 00380659982750 ()
  • 20380659982754 ()


  • Ophthalmic laser system eyeball positioning suction cup

VERION™ - 00380659982705

VERION™ Digital Marker M
Alcon Laboratories, Inc.
8065998270
In Commercial Distribution

  • 00380659982705 ()


  • Bench-top keratometer

VERION™ - 00380659982682

VERION™ Reference Unit
Alcon Laboratories, Inc.
8065998268
In Commercial Distribution

  • 00380659982682 ()


  • Bench-top keratometer

LenSx - 00380659981623

LenSx Laser System
Alcon Laboratories, Inc.
8065998162
In Commercial Distribution

  • 00380659981623 ()


  • Femtosecond ophthalmic solid-state laser system

SatinShortCut - 00380659956614

SatinShortCut Implant Knife 5.2mm Angled
Alcon Laboratories, Inc.
8065995661
In Commercial Distribution

  • 10380659956611 ()
  • 00380659956614 ()


  • Ophthalmic knife, single-use

SatinSlit® - 00380659932618

SatinSlit® Knife 3.2mm Angled
Alcon Laboratories, Inc.
8065993261
In Commercial Distribution

  • 10380659932615 ()
  • 00380659932618 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380659930485

ClearCut® HP Slit Knife Dual Bevel 3.0mm Angled
Alcon Laboratories, Inc.
8065993048
Not in Commercial Distribution

  • 10380659930482 ()
  • 00380659930485 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380659930454

ClearCut® Slit Knife 3.0mm Angled
Alcon Laboratories, Inc.
8065993045
In Commercial Distribution

  • 10380659930451 ()
  • 00380659930454 ()


  • Ophthalmic knife, single-use

SatinSlit® - 00380659929618

SatinSlit® Knife 3.0mm Angled
Alcon Laboratories, Inc.
8065992961
Not in Commercial Distribution

  • 10380659929615 ()
  • 00380659929618 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380659928482

ClearCut® HP Slit Knife Dual Bevel 2.8mm Angled
Alcon Laboratories, Inc.
8065992848
Not in Commercial Distribution

  • 10380659928489 ()
  • 00380659928482 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380659927478

ClearCut® Slit Knife Dual Bevel 2.75mm Angled
Alcon Laboratories, Inc.
8065992747
In Commercial Distribution

  • 10380659927475 ()
  • 00380659927478 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380659926488

ClearCut® HP Slit Knife Dual Bevel 2.6mm Angled
Alcon Laboratories, Inc.
8065992648
Not in Commercial Distribution

  • 10380659926485 ()
  • 00380659926488 ()


  • Ophthalmic knife, single-use

SatinSlit® - 00380659925610

SatinSlit® Knife 2.5mm Angled
Alcon Laboratories, Inc.
8065992561
In Commercial Distribution

  • 10380659925617 ()
  • 00380659925610 ()


  • Ophthalmic knife, single-use

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

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

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
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