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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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CONSTELLATION® HYPERVIT® ENGAUGE® - 00380658300234

27+ HYPERVIT® Vitrectomy Probe
Alcon Laboratories, Inc.
8065830023
Not in Commercial Distribution

  • 10380658300231 ()
  • 00380658300234 ()


  • Vitrectomy system handpiece

CONSTELLATION® HYPERVIT® ENGAUGE® - 00380658300227

25+ HYPERVIT® Vitrectomy Probe
Alcon Laboratories, Inc.
8065830022
Not in Commercial Distribution

  • 10380658300224 ()
  • 00380658300227 ()


  • Vitrectomy system handpiece

ULTRA FLOW - 00380658176013

ULTRAFLOW S/P CURVED TIP, .3 mm
Alcon Laboratories, Inc.
00380658176013
Not in Commercial Distribution

  • 00380658176013 ()


  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

ULTRAFLOW - 00380658175016

ULTRAFLOW SP IRRIGATION ONLY
Alcon Laboratories, Inc.
00380658175016
Not in Commercial Distribution

  • 00380658175016 ()


  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

ULTRA FLOW - 00380658173012

ULTRAFLOW S/P 90 BENT TIP, .3 mm
Alcon Laboratories, Inc.
00380658173012
Not in Commercial Distribution

  • 00380658173012 ()


  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

ULTRA FLOW - 00380658172015

ULTRAFLOW S/P 45 BENT TIP, .3MM
Alcon Laboratories, Inc.
00380658172015
Not in Commercial Distribution

  • 00380658172015 ()


  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

ULTRA FLOW - 00380658170011

ULTRAFLOW S/P STRAIGHT TIP, .3MM
Alcon Laboratories, Inc.
00380658170011
Not in Commercial Distribution

  • 00380658170011 ()


  • Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

MVS - 00380658120016

FIBER OPTIC LIGHT GUIDE, Tip: .89mm (20GA)
Alcon Laboratories, Inc.
8065812001
Not in Commercial Distribution

  • 10380658120013 ()
  • 00380658120016 ()

  • 20 Gauge


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

VGFI - 00380658080020

VGFI Tubing Set
Alcon Laboratories, Inc.
8065808002
Not in Commercial Distribution

  • 10380658080027 ()
  • 00380658080020 ()


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

ISPAN - 00380657973033

ISPAN Medical Regulator
Alcon Laboratories, Inc.
8065797303
In Commercial Distribution

  • 00380657973033 ()


  • Intraocular gas cylinder regulator

ISPAN - 00380657971053

ISPAN C3F8 CONSTELLATION 125GM
Alcon Laboratories, Inc.
8065797105
In Commercial Distribution

  • 00380657971053 ()

  • Weight: 125 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657971046

TANK C3F8 CONSTELLATION LD4
Alcon Laboratories, Inc.
8065797104
Not in Commercial Distribution

  • 00380657971046 ()

  • Weight: 450 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657971039

ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797103
Not in Commercial Distribution

  • 00380657971039 ()

  • Weight: 25 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657971022

ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797102
In Commercial Distribution

  • 00380657971022 ()

  • Weight: 125 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657971015

ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797101
Not in Commercial Distribution

  • 00380657971015 ()

  • Weight: 450 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657970056

ISPAN SF6 CONSTELLATION 125GM
Alcon Laboratories, Inc.
8065797005
In Commercial Distribution

  • 00380657970056 ()

  • Weight: 125 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657970049

TANK SF6 CONSTELLATION LD5
Alcon Laboratories, Inc.
8065797004
Not in Commercial Distribution

  • 00380657970049 ()

  • Weight: 450 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657970032

ISPAN SF6 SULPHUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 22,200. Residual ISPAN* SF6 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797003
Not in Commercial Distribution

  • 00380657970032 ()

  • Weight: 20 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657970025

ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 22,200. Residual ISPAN* SF6 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797002
In Commercial Distribution

  • 00380657970025 ()

  • Weight: 125 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657970018

ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 22,200. Residual ISPAN* SF6 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797001
Not in Commercial Distribution

  • 00380657970018 ()

  • Weight: 450 Gram
8065797001

  • Vitreous/aqueous humour replacement medium, intraoperative

Alcon, Kelman, TurboSonics, ABS, MicroTip - 00380657900190

0° Round, 0.9 mm TurboSonics® ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065790019
Not in Commercial Distribution

  • 10380657900197 ()
  • 00380657900190 ()

  • Outer Diameter: 0.9 Millimeter
  • Angle: 0 degree


  • Phacoemulsification system handpiece tip, single-use

ClearCut® - 00380657730018

ClearCut® S Safety SAB Sideport Knife 30 °
Alcon Laboratories, Inc.
8065773001
In Commercial Distribution

  • 10380657730015 ()
  • 00380657730018 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380657727452

ClearCut® S Safety Slit Knife 2.75mm SB Angled
Alcon Laboratories, Inc.
8065772745
In Commercial Distribution

  • 10380657727459 ()
  • 00380657727452 ()


  • Ophthalmic knife, single-use

ClearCut®; Intrepid - 00380657724659

ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.4 DB
Alcon Laboratories, Inc.
8065772465
In Commercial Distribution

  • 10380657724656 ()
  • 00380657724659 ()


  • Ophthalmic knife, single-use

ClearCut®; Intrepid - 00380657724451

ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.4 SB
Alcon Laboratories, Inc.
8065772445
In Commercial Distribution

  • 10380657724458 ()
  • 00380657724451 ()


  • Ophthalmic knife, single-use

ClearCut®; Intrepid - 00380657722655

ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.2 DB
Alcon Laboratories, Inc.
8065772265
In Commercial Distribution

  • 10380657722652 ()
  • 00380657722655 ()


  • Ophthalmic knife, single-use

ClearCut®; Intrepid - 00380657722457

ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.2 SB
Alcon Laboratories, Inc.
8065772245
In Commercial Distribution

  • 10380657722454 ()
  • 00380657722457 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380657715411

ClearCut® S Safety Sideport Knife 1.2mm DB Angled
Alcon Laboratories, Inc.
8065771541
In Commercial Distribution

  • 10380657715418 ()
  • 00380657715411 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380657715404

ClearCut® S Safety Sideport Knife 1.0mm DB Angled
Alcon Laboratories, Inc.
8065771540
In Commercial Distribution

  • 10380657715401 ()
  • 00380657715404 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380657715015

ClearCut® S Safety SAB Sideport Knife 15 °
Alcon Laboratories, Inc.
8065771501
In Commercial Distribution

  • 10380657715012 ()
  • 00380657715015 ()


  • Ophthalmic knife, single-use

ClearCut® - 00380657700028

ClearCut® S Safety Cresent Knife 2.3mm Angled Bevel Up
Alcon Laboratories, Inc.
8065770002
In Commercial Distribution

  • 10380657700025 ()
  • 00380657700028 ()


  • Ophthalmic knife, single-use

UNITY - 00380657531790

25+ 30K Vitrectomy Probe
Alcon Laboratories, Inc.
00380657531790
In Commercial Distribution

  • 10380657531797 ()
  • 00380657531790 ()

  • 25 Gauge
8065753179

  • Vitrectomy system micro-cutting unit

UNITY - 00380657531776

27+™ UltraVit™ 10K Probe
Alcon Laboratories, Inc.
00380657531776
In Commercial Distribution

  • 10380657531773 ()
  • 00380657531776 ()
8065753177

  • Vitrectomy system micro-cutting unit

UNITY - 00380657531769

25+ ULTRAVIT 10K Probe
Alcon Laboratories, Inc.
00380657531769
In Commercial Distribution

  • 10380657531766 ()
  • 00380657531769 ()

  • 25 Gauge
8065753176

  • Vitrectomy system micro-cutting unit

UNITY - 00380657531752

25GA 10K Long Vitrectomy Probe
Alcon Laboratories, Inc.
00380657531752
In Commercial Distribution

  • 10380657531759 ()
  • 00380657531752 ()

  • 25 Gauge
8065753175

  • Vitrectomy system micro-cutting unit

UNITY - 00380657531745

23GA UltraVit™ 10K Probe
Alcon Laboratories, Inc.
00380657531745
In Commercial Distribution

  • 10380657531742 ()
  • 00380657531745 ()
8065753174

  • Vitrectomy system micro-cutting unit

UNITY - 00380657531684

Anterior Vitrectomy Kit 7.5CPM 25+GA
Alcon Laboratories, Inc.
00380657531684
In Commercial Distribution

  • 10380657531681 ()
  • 00380657531684 ()

  • 25 Gauge
8065753168

  • Vitrectomy system micro-cutting unit

UNITY - 00380657531677

Anterior Vitrectomy Kit 7.5CPM 23GA
Alcon Laboratories, Inc.
00380657531677
In Commercial Distribution

  • 10380657531674 ()
  • 00380657531677 ()

  • 23 Gauge
8065753167

  • Vitrectomy system micro-cutting unit

CENTURION®, INTREPID® - 00380657531592

CENTURION® Vision System Active FMS w/ 0.9MM Infusion Sleeves 0.9MM 45° ABS* INTREPID Hybrid Tip
Alcon Laboratories, Inc.
8065753159
In Commercial Distribution

  • 10380657531599 ()
  • 00380657531592 ()


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

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
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