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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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Alcon Single-Piece PMMA Slant - 00380652538695

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),11.5mm LENGTH, 5.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ40BD
Not in Commercial Distribution

  • 00380652538695 ()

  • Diopter 12
MZ40BD.120

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380652538688

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),11.5mm LENGTH, 5.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ40BD
Not in Commercial Distribution

  • 00380652538688 ()

  • Diopter 11.5
MZ40BD.115

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380652538671

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),11.5mm LENGTH, 5.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ40BD
Not in Commercial Distribution

  • 00380652538671 ()

  • Diopter 11
MZ40BD.110

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380652538664

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),11.5mm LENGTH, 5.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ40BD
Not in Commercial Distribution

  • 00380652538664 ()

  • Diopter 10.5
MZ40BD.105

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA Slant - 00380652538657

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),11.5mm LENGTH, 5.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
MZ40BD
Not in Commercial Distribution

  • 00380652538657 ()

  • Diopter 10
MZ40BD.100

  • Posterior-chamber intraocular lens, pseudophakic

Mounting Kit, Alcon Revalia - 00811608019765

No Description
VOLK OPTICAL INC.
12640
In Commercial Distribution

  • 00811608019765 ()


  • General-purpose surgical microscope

Alcon Grieshaber 27+ Finesse - 07612717071452

27+® FINESSE® Flex Loop DSP
Alcon Laboratories, Inc.
338.27
In Commercial Distribution

  • 17612717071459 ()
  • 07612717071452 ()


  • Epiretinal/inner limiting membrane scraper, single-use

Alcon Grieshaber 25+ Finesse - 07612717071445

25+® FINESSE® Flex Loop DSP
Alcon Laboratories, Inc.
338.25P
In Commercial Distribution

  • 17612717071442 ()
  • 07612717071445 ()


  • Epiretinal/inner limiting membrane scraper, single-use

Alcon Grieshaber 27+ REVOLUTION - 07612717071315

27+® REVOLUTION DSP ILM Forceps
Alcon Laboratories, Inc.
711.44
In Commercial Distribution

  • 17612717071312 ()
  • 07612717071315 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Alcon Grieshaber Visco Canalostomy - 07612717000469

Visco Canalostomy Cannula, Tip 0.165 mm
Alcon Laboratories, Inc.
149.40
Not in Commercial Distribution

  • 07612717000469 ()


  • Exploratory blunt needle, single-use

Alcon Grieshaber 27+ REVOLUTION - 07612717071322

27+® REVOLUTION DSP Straight Scissors
Alcon Laboratories, Inc.
711.53
In Commercial Distribution

  • 17612717071329 ()
  • 07612717071322 ()


  • Intraocular scissors, probe-like, single-use

Alcon Grieshaber 27+ REVOLUTION - 07612717071308

27+® REVOLUTION DSP Endgrasping Forceps
Alcon Laboratories, Inc.
711.43
In Commercial Distribution

  • 17612717071305 ()
  • 07612717071308 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Alcon Grieshaber REVOLUTION 25+ - 07612717071148

25+® REVOLUTION DSP Serrated Forceps
Alcon Laboratories, Inc.
705.47P
In Commercial Distribution

  • 17612717071145 ()
  • 07612717071148 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Alcon Grieshaber Finesse MAXGrip - 07612717070974

GRIESHABER MAXGrip® Adv DSP Forceps Tip, 25G
Alcon Laboratories, Inc.
725.13
In Commercial Distribution

  • 17612717070971 ()
  • 07612717070974 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use

Alcon Grieshaber Finesse MAXGrip - 07612717070905

GRIESHABER MAXGrip® Adv DSPForceps Tip, 23G
Alcon Laboratories, Inc.
723.13
In Commercial Distribution

  • 17612717070902 ()
  • 07612717070905 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use

Alcon Grieshaber Finesse MAXGrip - 07612717070844

GRIESHABER MAXGrip® Adv DSP Forceps Tip, 20G
Alcon Laboratories, Inc.
720.13
Not in Commercial Distribution

  • 17612717070841 ()
  • 07612717070844 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use

Alcon Grieshaber REVOLUTION 25+ - 07612717070691

25+® REVOLUTION DSP Curved Scissors
Alcon Laboratories, Inc.
705.52P
In Commercial Distribution

  • 17612717070698 ()
  • 07612717070691 ()


  • Intraocular scissors, probe-like, single-use

Alcon Grieshaber REVOLUTION 25+ - 07612717070684

25+® REVOLUTION DSP Asymmetrical Forceps
Alcon Laboratories, Inc.
705.45P
In Commercial Distribution

  • 17612717070681 ()
  • 07612717070684 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Alcon Grieshaber REVOLUTION 25+ - 07612717070677

25+® REVOLUTION DSP Endgrasping Forceps
Alcon Laboratories, Inc.
705.43P
In Commercial Distribution

  • 17612717070674 ()
  • 07612717070677 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

Alcon Grieshaber REVOLUTION 25+ - 07612717070622

25+® REVOLUTION DSP ILM Forceps
Alcon Laboratories, Inc.
705.44P
In Commercial Distribution

  • 17612717070629 ()
  • 07612717070622 ()


  • Ophthalmic soft-tissue manipulation forceps, probe-like, single-use

MSI Precision Specialty Instruments - 00194613121921

Monarch II IOL Delivery System "A" Cartridges 10 Per Box Individually Packaged Sterile For Use With ALCON QUALIFIED AcrySof
Med Saver, Inc.
8065977757
In Commercial Distribution

  • 00194613121921 ()


  • Manual intraocular lens injector, reusable

25ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector - 10817489024932

25ga Tapered Flexible Curved Illuminated Laser Probe, Alcon/Coherent Laser Connector, Short 19ga Needle Illumination Connector, Box of 10
KATALYST SURGICAL LLC
V6315-25BV
Not in Commercial Distribution

  • 10817489024932 ()
  • 00817489024935 ()


  • Ophthalmic fibreoptic light instrument, single-use

23ga Tapered Flex Curved Illum Laser Probe, Alcon/Coherent Laser Connector - 10817489024925

23ga Tapered Flexible Curved Illuminated Laser Probe, Alcon/Coherent Laser Connector, Short 19ga Needle Illumination Connector, Box of 10
KATALYST SURGICAL LLC
V6315-23BV
Not in Commercial Distribution

  • 10817489024925 ()
  • 00817489024928 ()


  • Ophthalmic fibreoptic light instrument, single-use

iLux - 00864461000418

No Description
Alcon Laboratories, Inc.
2020-D
In Commercial Distribution

  • 00864461000418 ()
  • 10864461000415 ()
2020-D

  • Eyelid thermal pulsation system applicator, single-use

iLux - 00864461000401

No Description
Alcon Laboratories, Inc.
2020
In Commercial Distribution

  • 00864461000401 ()
2020

  • Eyelid thermal pulsation system control unit

CLEAR CARE - 00047113709338

CLEAR CARE 3 oz
Alcon Laboratories, Inc.
Clear Care 3oz
Not in Commercial Distribution

  • 00047113709338 ()


  • Multi-purpose soft/rigid contact lens solution

Clear Care - 00047113609126

Clear Care Cleaning & Disinfecting Solution 12 oz.
Alcon Laboratories, Inc.
Clear Care 12oz
Not in Commercial Distribution

  • 00047113609126 ()
  • 20300650358204 ()


  • Multi-purpose soft/rigid contact lens solution

Clear Care - 00047113609034

Clear Care Cleaning & Disinfecting Solution 3 oz. Travel Kit
Alcon Laboratories, Inc.
Clear Care 3oz
Not in Commercial Distribution

  • 00047113609034 ()
  • 20300650358235 ()


  • Multi-purpose soft/rigid contact lens solution

Clear Care - 00047113609027

Clear Care Cleaning & Disinfecting Solution Twin Pack 2 x 12 oz.
Alcon Laboratories, Inc.
Clear Care 2x12oz
Not in Commercial Distribution

  • 00047113609027 ()
  • 20300650358211 ()


  • Multi-purpose soft/rigid contact lens solution

Clear Care - 00047113604978

Clear Care Cleaning & Disinfecting Solution Twin Pack 2 x 16 oz. plus 3 oz. Travel Size
Alcon Laboratories, Inc.
Clear Care 2x16oz plus 3 oz
Not in Commercial Distribution

  • 00047113604978 ()
  • 20300650358266 ()
  • 20300650358259 ()


  • Multi-purpose soft/rigid contact lens solution

ACRYSOF, IQ RESTOR - 00380652270540

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.45
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270540 ()

  • Diopter 16
SND1T4U160

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270533

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.44
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270533 ()

  • Diopter 15.5
SND1T4U155

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270526

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.43
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270526 ()

  • Diopter 15
SND1T4U150

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270496

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.40
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270496 ()

  • Diopter 13.5
SND1T4U135

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270489

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.39
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270489 ()

  • Diopter 13
SND1T4U130

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270465

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.37
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270465 ()

  • Diopter 12
SND1T4U120

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652270342

Acrysof IQ ReStor Multifocal Toric IOL, STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 2.25
Alcon Laboratories, Inc.
SND1T4
Not in Commercial Distribution

  • 00380652270342 ()

  • Diopter 6
SND1T4U060

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269223

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269223 ()

  • Diopter 29.5
SND1T3U295

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269209

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269209 ()

  • Diopter 28.5
SND1T3U285

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269186

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269186 ()

  • Diopter 27.5
SND1T3U275

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269155

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269155 ()

  • Diopter 26.0
SND1T3U260

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269131

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269131 ()

  • Diopter 25.0
SND1T3U250

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269124

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269124 ()

  • Diopter 24.5
SND1T3U245

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269117

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269117 ()

  • Diopter 24.0
SND1T3U240

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269100

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269100 ()

  • Diopter 23.5
SND1T3U235

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269094

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269094 ()

  • Diopter 23.0
SND1T3U230

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269087

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269087 ()

  • Diopter 22.5
SND1T3U225

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269070

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269070 ()

  • Diopter 22.0
SND1T3U220

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269063

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269063 ()

  • Diopter 21.5
SND1T3U215

  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF, IQ RESTOR - 00380652269056

Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50
Alcon Laboratories, Inc.
SND1T3
Not in Commercial Distribution

  • 00380652269056 ()

  • Diopter 21.0
SND1T3U210

  • Posterior-chamber intraocular lens, pseudophakic
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