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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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LuxOR - 00380657530625

Surgical Microscope System
Alcon Laboratories, Inc.
00380657530625
In Commercial Distribution

  • 00380657530625 ()


  • Ophthalmic surgical microscope

Centurion - 00380657530571

Centurion Vision System With Active Sentry
Alcon Laboratories, Inc.
8065753057
In Commercial Distribution

  • 00380657530571 ()


  • Phacoemulsification system

CONSTELLATION - 00380657530410

CONSTELLATION TABLE TOP
Alcon Laboratories, Inc.
8065753041
In Commercial Distribution

  • 00380657530410 ()


  • Phacoemulsification/vitrectomy system generator

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

LuxOR - 00380657525683

Surgical Microscope System
Alcon Laboratories, Inc.
00380657525683
In Commercial Distribution

  • 00380657525683 ()


  • Ophthalmic surgical microscope

LuxOR - 00380657525676

Surgical Microscope System
Alcon Laboratories, Inc.
00380657525676
Not in Commercial Distribution

  • 00380657525676 ()


  • Ophthalmic surgical microscope

LUXOR - 00380657525669

LUXOR Opthalmic Microscope Footswitch
Alcon Laboratories, Inc.
8065752566
In Commercial Distribution

  • 00380657525669 ()


  • General-purpose surgical microscope

LuxOR - 00380657525607

Surgical Microscope System
Alcon Laboratories, Inc.
00380657525607
In Commercial Distribution

  • 00380657525607 ()


  • Ophthalmic surgical microscope

Engauge, Vektor - 00380657525560

27GA ARTICULATING ILLUMINATED LASER PROBE
Alcon Laboratories, Inc.
8065752556
In Commercial Distribution

  • 10380657525567 ()
  • 00380657525560 ()

  • 27 Gauge


  • Ophthalmic laser system beam guide

Engauge, Vektor - 00380657525553

25GA ARTICULATING ILLUMINATED LASER PROBE
Alcon Laboratories, Inc.
8065752555
In Commercial Distribution

  • 10380657525550 ()
  • 00380657525553 ()

  • 25 Gauge


  • Ophthalmic laser system beam guide

Engauge, Vektor - 00380657525546

23GA ARTICULATING ILLUMINATED LASER PROBE
Alcon Laboratories, Inc.
8065752554
In Commercial Distribution

  • 10380657525543 ()
  • 00380657525546 ()

  • 23 Gauge


  • Ophthalmic laser system beam guide

CONSTELLATION - 00380657525379

CONSTELLATION CR4 UPGRADE KIT
Alcon Laboratories, Inc.
8065752537
Not in Commercial Distribution

  • 00380657525379 ()


  • Phacoemulsification/vitrectomy system generator

CENTURION® - 00380657525270

CENTURION® VISION SYSTEM RECONSTITUTION RACK
Alcon Laboratories, Inc.
8065752527
In Commercial Distribution

  • 00380657525270 ()


  • Medical device integration rack

Constellation, ULTRAVIT, EdgePlus, TotalPlus - 00380657524525

27+* TOTALPLUS* Combined Procedure Pak Beveled 10,000 CPM ULTRAVIT* Probe Straight Endo 0.9 Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752452
In Commercial Distribution

  • 10380657524522 ()
  • 00380657524525 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524518

25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752451
In Commercial Distribution

  • 10380657524515 ()
  • 00380657524518 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524501

25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752450
In Commercial Distribution

  • 10380657524508 ()
  • 00380657524501 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524495

23 GA TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752449
In Commercial Distribution

  • 10380657524492 ()
  • 00380657524495 ()


  • Vitrectomy system handpiece

Constellation, ULTRAVIT, EdgePlus, TotalPlus - 00380657524488

23 GA TOTALPLUS* Combined Procedure Pak Beveled 10,000 CPM ULTRAVIT* Probe Straight Endo 0.9 Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752448
In Commercial Distribution

  • 10380657524485 ()
  • 00380657524488 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524396

27+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
Alcon Laboratories, Inc.
8065752439
In Commercial Distribution

  • 10380657524393 ()
  • 00380657524396 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524389

25+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator
Alcon Laboratories, Inc.
8065752438
In Commercial Distribution

  • 10380657524386 ()
  • 00380657524389 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524372

25+ TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
Alcon Laboratories, Inc.
8065752437
In Commercial Distribution

  • 10380657524379 ()
  • 00380657524372 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524365

23 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator
Alcon Laboratories, Inc.
8065752436
In Commercial Distribution

  • 10380657524362 ()
  • 00380657524365 ()


  • Vitrectomy system handpiece

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT - 00380657524358

23 GA TOTAL PLUS Vitrectory Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator
Alcon Laboratories, Inc.
8065752435
In Commercial Distribution

  • 10380657524355 ()
  • 00380657524358 ()


  • Vitrectomy system handpiece

Constellation, ULTRAVIT, Engauge, 27+ - 00380657524174

27+* ULTRAVIT* Vitrectomy Probe Beveled 27+* /10,000 CPM
Alcon Laboratories, Inc.
8065752417
In Commercial Distribution

  • 10380657524171 ()
  • 00380657524174 ()


  • Vitrectomy system handpiece

Constellation, ULTRAVIT, Engauge, 25+ - 00380657524150

25+* ULTRAVIT* Vitrectomy Probe Beveled 25+* /10,000 CPM
Alcon Laboratories, Inc.
8065752415
In Commercial Distribution

  • 10380657524157 ()
  • 00380657524150 ()


  • Vitrectomy system handpiece

Constellation, ULTRAVIT, Engauge - 00380657524136

23 GA ULTRAVIT*  Vitrectomy Probe Beveled 23 GA/10,000 CPM
Alcon Laboratories, Inc.
8065752413
In Commercial Distribution

  • 10380657524133 ()
  • 00380657524136 ()


  • Vitrectomy system handpiece

27+® Infusion Cannula w/Tray - 00380657521739

27+® Infusion Cannula w/Tray; .43mm (27+®) Infusion Cannula w/Tray
Alcon Laboratories, Inc.
8065752173
In Commercial Distribution

  • 10380657521736 ()
  • 00380657521739 ()

  • 27 Gauge


  • Vitrectomy system handpiece

Infiniti - 00380657521609

Infiniti Vision System
Alcon Laboratories, Inc.
8065752160
In Commercial Distribution

  • 00380657521609 ()


  • Phacoemulsification system generator

Constellation - 00380657521517

25GA Infustion Cannula w/ Tray
Alcon Laboratories, Inc.
8065752151
In Commercial Distribution

  • 10380657521514 ()
  • 00380657521517 ()


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

Constellation - 00380657521494

23GA Infustion Cannula w/ Tray
Alcon Laboratories, Inc.
8065752149
In Commercial Distribution

  • 10380657521491 ()
  • 00380657521494 ()


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

27+® Infusion Cannula w/Tray - 00380657521258

27+® Infusion Cannula w/Tray; .43mm (27+®) Infusion Cannula w/Tray
Alcon Laboratories, Inc.
8065752125
In Commercial Distribution

  • 10380657521255 ()
  • 00380657521258 ()

  • 27 Gauge


  • Vitrectomy system handpiece
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