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

  • 00380657530939 ()


  • Automated ophthalmic refractometer
Microsurgical Camera
Alcon Laboratories, Inc.
00380657530915
In Commercial Distribution

  • 00380657530915 ()


  • Microscope video camera
Surgical Microscope
Alcon Laboratories, Inc.
00380657530731
In Commercial Distribution

  • 00380657530731 ()


  • Ophthalmic surgical microscope
Surgical Microscope
Alcon Laboratories, Inc.
00380657530724
In Commercial Distribution

  • 00380657530724 ()


  • Ophthalmic surgical microscope
Surgical Microscope
Alcon Laboratories, Inc.
00380657530717
In Commercial Distribution

  • 00380657530717 ()


  • Ophthalmic surgical microscope
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 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
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753067
In Commercial Distribution

  • 10380657530677 ()
  • 00380657530670 ()
8065753067

  • Sulfur hexafluoride refillable cylinder
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753066
In Commercial Distribution

  • 10380657530660 ()
  • 00380657530663 ()
8065753066

  • Perfluoropropane refillable cylinder
Surgical Microscope System
Alcon Laboratories, Inc.
00380657530656
In Commercial Distribution

  • 00380657530656 ()


  • Ophthalmic surgical microscope
Surgical Microscope System
Alcon Laboratories, Inc.
00380657530632
Not in Commercial Distribution

  • 00380657530632 ()


  • Ophthalmic surgical microscope
Surgical Microscope System
Alcon Laboratories, Inc.
00380657530625
In Commercial Distribution

  • 00380657530625 ()


  • Ophthalmic surgical microscope
Centurion Vision System With Active Sentry
Alcon Laboratories, Inc.
8065753057
In Commercial Distribution

  • 00380657530571 ()


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

  • 00380657530410 ()


  • Phacoemulsification/vitrectomy system generator
ORA System with VerifEyeTM Lynk, Cart
Alcon Laboratories, Inc.
8065753003
In Commercial Distribution

  • 00380657530038 ()


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

  • 00380657530014 ()


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

  • 00380657530007 ()


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

  • 00380657529995 ()


  • Automated ophthalmic refractometer
Purepoint Laser
Alcon Laboratories, Inc.
8065752987
In Commercial Distribution

  • 00380657529872 ()


  • Indirect binocular laser ophthalmoscope
Centurion Vision System Active Sentry® Handpiece
Alcon Laboratories, Inc.
8065752914
In Commercial Distribution

  • 00380657529148 ()


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

  • 10380657529008 ()
  • 00380657529001 ()


  • Vitrectomy system handpiece
INTREPID® Transformer IA HP
Alcon Laboratories, Inc.
8065752885
In Commercial Distribution

  • 10380657528858 ()
  • 00380657528851 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Surgical Microscope System
Alcon Laboratories, Inc.
00380657525706
In Commercial Distribution

  • 00380657525706 ()


  • Ophthalmic surgical microscope
Surgical Microscope System
Alcon Laboratories, Inc.
00380657525683
In Commercial Distribution

  • 00380657525683 ()


  • Ophthalmic surgical microscope
Surgical Microscope System
Alcon Laboratories, Inc.
00380657525676
Not in Commercial Distribution

  • 00380657525676 ()


  • Ophthalmic surgical microscope
LUXOR Opthalmic Microscope Footswitch
Alcon Laboratories, Inc.
8065752566
In Commercial Distribution

  • 00380657525669 ()


  • General-purpose surgical microscope
Surgical Microscope System
Alcon Laboratories, Inc.
00380657525607
In Commercial Distribution

  • 00380657525607 ()


  • Ophthalmic surgical microscope
27GA ARTICULATING ILLUMINATED LASER PROBE
Alcon Laboratories, Inc.
8065752556
In Commercial Distribution

  • 10380657525567 ()
  • 00380657525560 ()

  • 27 Gauge


  • Ophthalmic laser system beam guide
25GA ARTICULATING ILLUMINATED LASER PROBE
Alcon Laboratories, Inc.
8065752555
In Commercial Distribution

  • 10380657525550 ()
  • 00380657525553 ()

  • 25 Gauge


  • Ophthalmic laser system beam guide
23GA ARTICULATING ILLUMINATED LASER PROBE
Alcon Laboratories, Inc.
8065752554
In Commercial Distribution

  • 10380657525543 ()
  • 00380657525546 ()

  • 23 Gauge


  • Ophthalmic laser system beam guide
CONSTELLATION CR4 UPGRADE KIT
Alcon Laboratories, Inc.
8065752537
Not in Commercial Distribution

  • 00380657525379 ()


  • Phacoemulsification/vitrectomy system generator
CENTURION® VISION SYSTEM RECONSTITUTION RACK
Alcon Laboratories, Inc.
8065752527
In Commercial Distribution

  • 00380657525270 ()


  • Medical device integration rack
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
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