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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™ - 00380657530038

ORA System with VerifEyeTM Lynk, Cart
Alcon Laboratories, Inc.
8065753003
In Commercial Distribution

  • 00380657530038 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657530014

ORA System with VerifEyeTM Lynk, Aberrometer 195.5
Alcon Laboratories, Inc.
8065753001
In Commercial Distribution

  • 00380657530014 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657530007

ORA System with VerifEyeTM Lynk, Aberrometer 190.5
Alcon Laboratories, Inc.
8065753000
In Commercial Distribution

  • 00380657530007 ()


  • Automated ophthalmic refractometer

ORA System® VerifEye™ - 00380657529995

ORA System with VerifEyeTM Lynk, Aberrometer 184.5
Alcon Laboratories, Inc.
8065752999
In Commercial Distribution

  • 00380657529995 ()


  • Automated ophthalmic refractometer

Purepoint - 00380657529872

Purepoint Laser
Alcon Laboratories, Inc.
8065752987
In Commercial Distribution

  • 00380657529872 ()


  • Indirect binocular laser ophthalmoscope

CENTURION® - 00380657529148

Centurion Vision System Active Sentry® Handpiece
Alcon Laboratories, Inc.
8065752914
In Commercial Distribution

  • 00380657529148 ()


  • Phacoemulsification system handpiece

CENTURION® INTREPID® - 00380657529018

SMALL PARTS KIT W/ INTREPID® NANO SLEEVES 0.9 MM Tipless
Alcon Laboratories, Inc.
8065752901
In Commercial Distribution

  • 10380657529015 ()
  • 00380657529018 ()


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

CENTURION, Interpid - 00380657529001

SMALL PARTS KIT W/ INTREPID* ULTRA SLEEVES 0.9 MM Tipless
Alcon Laboratories, Inc.
8065752900
In Commercial Distribution

  • 10380657529008 ()
  • 00380657529001 ()


  • Vitrectomy system handpiece

INTREPID® - 00380657528851

INTREPID® Transformer IA HP
Alcon Laboratories, Inc.
8065752885
In Commercial Distribution

  • 10380657528858 ()
  • 00380657528851 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

LuxOR - 00380657525706

Surgical Microscope System
Alcon Laboratories, Inc.
00380657525706
In Commercial Distribution

  • 00380657525706 ()


  • Ophthalmic surgical microscope
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