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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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CENTURION®, INTREPID® - 00380657531431

CENTURION® Vision System Gravity FMS w/ INTREPID® Ultra Sleeves 0.9MM 45° ABS* INTREPID Hybrid Tip
Alcon Laboratories, Inc.
8065753143
In Commercial Distribution

  • 10380657531438 ()
  • 00380657531431 ()


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

CENTURION®, INTREPID® - 00380657531370

CENTURION® Vision System Active FMS w/ INTREPID Nano Sleeves, 0.9MM 45° ABS* INTERPID Hybrid Tip
Alcon Laboratories, Inc.
8065753137
In Commercial Distribution

  • 10380657531377 ()
  • 00380657531370 ()


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

CENTURION® INTREPID® - 00380657531363

Active FMS w INTERPID Nano Sleeves 0.9MM 30° ABS* INTERPID Hybrid Tip
Alcon Laboratories, Inc.
8065753136
In Commercial Distribution

  • 10380657531360 ()
  • 00380657531363 ()


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

CENTURION®, INTREPID® - 00380657531356

CENTURION® Vision System Active FMS w/ INTREPID Ultra Sleeves, 0.9MM 45° ABS* INTERPID Hybrid Tip
Alcon Laboratories, Inc.
8065753135
In Commercial Distribution

  • 10380657531353 ()
  • 00380657531356 ()


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

CENTURION® INTREPID® - 00380657531349

Active FMS w INTERPID Ultra Sleeves 0.9MM 30° ABS* INTERPID Hybrid Tip
Alcon Laboratories, Inc.
8065753134
In Commercial Distribution

  • 10380657531346 ()
  • 00380657531349 ()


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

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380657531097

27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Vitrectomy Pak
Alcon Laboratories, Inc.
8065753109
In Commercial Distribution

  • 10380657531094 ()
  • 00380657531097 ()


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

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380657531066

25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Vitrectomy Pak
Alcon Laboratories, Inc.
8065753106
In Commercial Distribution

  • 10380657531063 ()
  • 00380657531066 ()


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

ORA System® VerifEye™ - 00380657530939

ORA System with VerifEyeTM+ 2.0, Cart
Alcon Laboratories, Inc.
8065753093
In Commercial Distribution

  • 00380657530939 ()


  • Automated ophthalmic refractometer

Ngenuity - 00380657530915

Microsurgical Camera
Alcon Laboratories, Inc.
00380657530915
In Commercial Distribution

  • 00380657530915 ()


  • Microscope video camera

LuxOR Revalia - 00380657530731

Surgical Microscope
Alcon Laboratories, Inc.
00380657530731
In Commercial Distribution

  • 00380657530731 ()


  • Ophthalmic surgical microscope

LuxOR Revalia - 00380657530724

Surgical Microscope
Alcon Laboratories, Inc.
00380657530724
In Commercial Distribution

  • 00380657530724 ()


  • Ophthalmic surgical microscope

LuxOR Revalia - 00380657530717

Surgical Microscope
Alcon Laboratories, Inc.
00380657530717
In Commercial Distribution

  • 00380657530717 ()


  • Ophthalmic surgical microscope

UNIPURE & UNIPEXY - 00380657530694

UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753069
In Commercial Distribution

  • 10380657530691 ()
  • 00380657530694 ()
8065753069

  • Sulfur hexafluoride refillable cylinder

UNIPURE & UNIPEXY - 00380657530687

UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753068
In Commercial Distribution

  • 10380657530684 ()
  • 00380657530687 ()
8065753068

  • Perfluoropropane refillable cylinder

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, 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 - 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, 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 - 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

Constellation, Ultravit, 25+, TotalPlus, Engauge - 00380657520701

Constellation Vision System 7500 CPM UltraVit Probe Straight Endoilluminator 25+ Short TotalPlus Combined Procedure Pak Engauge RFID 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752070
Not in Commercial Distribution

  • 10380657520708 ()
  • 00380657520701 ()

  • 25 Gauge


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

Constellation, Ultravit, 27+, TotalPlus, EdgePlus - 00380657520626

Constellation Vision System 7500 CPM UltraVit Probe Straight Endoilluminator 27+ TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065752062
In Commercial Distribution

  • 10380657520623 ()
  • 00380657520626 ()

  • 27 Gauge


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

Constellation, Ultravit, 27+, TotalPlus, EdgePlus - 00380657520596

Constellation Vision System 7500 CPM UltraVit Probe Straight Endoilluminator 27+ TotalPlus Combined Procedure Pak EdgePlus Blade Valved Entry System 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065752059
In Commercial Distribution

  • 10380657520593 ()
  • 00380657520596 ()

  • 27 Gauge


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

Constellation, Ultravit, 25+, TotalPlus, EdgePlus - 00380657519101

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 25+ TotalPlus Combined Procedure Pak EdgePlus Blade Valved Entry System 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065751910
Not in Commercial Distribution

  • 10380657519108 ()
  • 00380657519101 ()

  • 25 Gauge


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

Constellation, Ultravit, TotalPlus, EdgePlus - 00380657519088

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 23 GA TotalPlus Combined Procedure Pak EdgePlus Blade Valved Entry System 0.9 mm Tipless Anterior Kit
Alcon Laboratories, Inc.
8065751908
Not in Commercial Distribution

  • 10380657519085 ()
  • 00380657519088 ()

  • 23 Gauge


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

Constellation, Ultravit, 25+, TotalPlus, EdgePlus - 00380657519033

Constellation Vision System 5000 CPM UltraVit Probe Wide Angle Endoilluminator 25+ TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751903
Not in Commercial Distribution

  • 10380657519030 ()
  • 00380657519033 ()

  • 25 Gauge


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

Constellation, Ultravit, 25+, TotalPlus, EdgePlus - 00380657519026

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 25+ TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751902
Not in Commercial Distribution

  • 10380657519023 ()
  • 00380657519026 ()

  • 25 Gauge


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

Constellation, Ultravit, TotalPlus, EdgePlus - 00380657519019

Constellation Vision System 5000 CPM UltraVit Probe Wide Angle Endoilluminator 23 GA TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751901
Not in Commercial Distribution

  • 10380657519016 ()
  • 00380657519019 ()

  • 23 Gauge


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

Constellation, Ultravit, TotalPlus, EdgePlus - 00380657519002

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 23 GA TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
Alcon Laboratories, Inc.
8065751900
Not in Commercial Distribution

  • 10380657519009 ()
  • 00380657519002 ()

  • 23 Gauge


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

Constellation - 00380657518852

Constellation Vision System Basic Combined Procedure Pak
Alcon Laboratories, Inc.
8065751885
In Commercial Distribution

  • 10380657518859 ()
  • 00380657518852 ()


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