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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, Kelman, TurboSonics, Mini-Flared ABS - 00380657508525

30° Kelman®, 0.9 mm TurboSonics® Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065750852
In Commercial Distribution

  • 10380657508522 ()
  • 00380657508525 ()

  • Outer Diameter: 0.9 Millimeter
  • Angle: 30 degree


  • Phacoemulsification system handpiece tip, single-use

PUREPOINT - 00380657505975

PUREPOINT LASER SYSTEM
Alcon Laboratories, Inc.
8065750597
In Commercial Distribution

  • 00380657505975 ()


  • General/multiple surgical frequency-doubled solid-state laser system

Laureate - 00380657505425

0.9 MM Laureate
Alcon Laboratories, Inc.
8065750542
In Commercial Distribution

  • 10380657505422 ()
  • 00380657505425 ()

  • Outer Diameter: 0.9 Millimeter


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

Laureate - 00380657505418

Basic Laureate
Alcon Laboratories, Inc.
8065750541
In Commercial Distribution

  • 10380657505415 ()
  • 00380657505418 ()


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

Laureate - 00380657504701

Laureate Anterior Vitrectomy Handpiece
Alcon Laboratories, Inc.
8065750470
In Commercial Distribution

  • 00380657504701 ()


  • Phacoemulsification system handpiece

Ozil - 00380657504695

Ozil Handpiece
Alcon Laboratories, Inc.
8065750469
In Commercial Distribution

  • 00380657504695 ()


  • Phacoemulsification system handpiece

Infiniti - 00380657504688

Infiniti Remote control
Alcon Laboratories, Inc.
8065750468
In Commercial Distribution

  • 00380657504688 ()


  • Foot-switch, electrical

Infiniti - 00380657504039

Enhanced Footswitch, Infiniti
Alcon Laboratories, Inc.
8065750403
In Commercial Distribution

  • 00380657504039 ()


  • Foot-switch, electrical

Infiniti - 00380657502936

Infiniti Ultrasound Multipak Basic Stand Alone
Alcon Laboratories, Inc.
8065750293
In Commercial Distribution

  • 10380657502933 ()
  • 00380657502936 ()


  • Foot-switch, electrical

Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip - 00380657502646

45° Kelman®, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065750264
In Commercial Distribution

  • 10380657502643 ()
  • 00380657502646 ()

  • Outer Diameter: 0.9 Millimeter
  • Angle: 45 degree


  • Phacoemulsification system handpiece tip, single-use

Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip - 00380657502639

30° Kelman®, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065750263
In Commercial Distribution

  • 10380657502636 ()
  • 00380657502639 ()

  • Outer Diameter: 0.9 Millimeter
  • Angle: 30 degree


  • Phacoemulsification system handpiece tip, single-use

Alcon, TurboSonics, Tapered ABS, MicroTip - 00380657502615

30° Round, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065750261
In Commercial Distribution

  • 10380657502612 ()
  • 00380657502615 ()

  • Angle: 30 degree
  • Outer Diameter: 0.9 Millimeter


  • Phacoemulsification system handpiece tip, single-use

Infiniti - 00380657501571

Anterior Vitrectomy Pak: Anterior Vitrectomy Probe w/21 GA Infusion Cannula
Alcon Laboratories, Inc.
8065750157
Not in Commercial Distribution

  • 10380657501578 ()
  • 00380657501571 ()

  • 21 Gauge


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

Infiniti - 00380657501212

Ultrasonic Handpiece
Alcon Laboratories, Inc.
8065750121
In Commercial Distribution

  • 00380657501212 ()


  • Phacoemulsification system handpiece

Alcon, Infiniti, MicroSmooth, Kelman, ABS - 00380657410880

0.9 mm 45° Kelman® ABS® Tip
Alcon Laboratories, Inc.
8065741088
Not in Commercial Distribution

  • 10380657410887 ()
  • 00380657410880 ()

  • Angle: 45 degree
  • Outer Diameter: 0.9 Millimeter


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

Alcon, Infiniti, MicroSmooth, Kelman, ABS - 00380657410873

0.9 mm 30° Kelman® ABS® Tip
Alcon Laboratories, Inc.
8065741087
In Commercial Distribution

  • 10380657410870 ()
  • 00380657410873 ()

  • Angle: 30 degree
  • Outer Diameter: 0.9 Millimeter


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

Accurus - 00380657409976

Accurus Six Switch Footpedal
Alcon Laboratories, Inc.
8065740997
In Commercial Distribution

  • 00380657409976 ()


  • Foot-switch, electrical

VGFI - 00380657409624

Combined Procedure VGFI Tubing Set
Alcon Laboratories, Inc.
8065740962
Not in Commercial Distribution

  • 10380657409621 ()
  • 00380657409624 ()


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

Alcon, TurboSonics, Flared ABS, MicroTip - 00380657408399

30° Kelman®, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065740839
Not in Commercial Distribution

  • 10380657408396 ()
  • 00380657408399 ()

  • Angle: 30 degree
  • Outer Diameter: 0.9 Millimeter


  • Phacoemulsification system handpiece tip, single-use

Alcon, TurboSonics, Flared ABS, MicroTip - 00380657408382

45° Round, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065740838
Not in Commercial Distribution

  • 10380657408389 ()
  • 00380657408382 ()

  • Angle: 45 degree
  • Outer Diameter: 0.9 Millimeter


  • Phacoemulsification system handpiece tip, single-use

Alcon, TurboSonics, Flared ABS, MicroTip - 00380657408375

30° Round, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip
Alcon Laboratories, Inc.
8065740837
In Commercial Distribution

  • 10380657408372 ()
  • 00380657408375 ()

  • Angle: 30 degree
  • Outer Diameter: 0.9 Millimeter


  • Phacoemulsification system handpiece tip, single-use

VGFI, Accurus - 00380657407019

Anterior VGFI tubing set, for use with Accurus Ophthalmic Surgical System
Alcon Laboratories, Inc.
8065740701
Not in Commercial Distribution

  • 10380657407016 ()
  • 00380657407019 ()


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

Ocutome - 00380657400034

Advanced Technology Irrigating Ocutome Probe
Alcon Laboratories, Inc.
1006
Not in Commercial Distribution

  • 10380657400031 ()
  • 00380657400034 ()


  • Vitrectomy system handpiece

A.C.S® (Alcon Closure System) - 00380657122011

Suture - Needle Type NU-S,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Single Armed
Alcon Laboratories, Inc.
8065712201
Not in Commercial Distribution

  • 10380657122018 ()
  • 00380657122011 ()

  • Length: 6 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380657121014

Suture - Needle Type NU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Double Armed
Alcon Laboratories, Inc.
8065712101
In Commercial Distribution

  • 00380657121014 ()
  • 10380657121011 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380657117017

Suture - Needle Type NU-l,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Double Armed
Alcon Laboratories, Inc.
8065711701
Not in Commercial Distribution

  • 10380657117014 ()
  • 00380657117017 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380657104017

Suture - Needle Type AU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Single Armed
Alcon Laboratories, Inc.
8065710401
In Commercial Distribution

  • 10380657104014 ()
  • 00380657104017 ()

  • Length: 6 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380657100019

Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,Single Armed
Alcon Laboratories, Inc.
8065710001
In Commercial Distribution

  • 10380657100016 ()
  • 00380657100019 ()

  • Length: 6 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380657021017

Suture - Needle Type AU-8,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Double Armed
Alcon Laboratories, Inc.
8065702101
Not in Commercial Distribution

  • 10380657021014 ()
  • 00380657021017 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380657020010

Suture - Needle Type AU-8,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 8,Double Armed
Alcon Laboratories, Inc.
8065702001
In Commercial Distribution

  • 10380657020017 ()
  • 00380657020010 ()

  • Length: 8 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380656980018

Suture - Needle Type AU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Double Armed
Alcon Laboratories, Inc.
8065698001
In Commercial Distribution

  • 10380656980015 ()
  • 00380656980018 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380656931010

Suture - Needle Type A-3,Black Monofilament Nylon(BMN), Suture Size 9-0, Suture Length 12, Double Armed
Alcon Laboratories, Inc.
8065693101
Not in Commercial Distribution

  • 10380656931017 ()
  • 00380656931010 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380656930013

Suture - Needle Type A-3,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Double Armed
Alcon Laboratories, Inc.
8065693001
In Commercial Distribution

  • 10380656930010 ()
  • 00380656930013 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380656921011

Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12, Double Armed
Alcon Laboratories, Inc.
8065692101
In Commercial Distribution

  • 10380656921018 ()
  • 00380656921011 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380656920014

Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, ,Suture Length 6,Double Armed
Alcon Laboratories, Inc.
8065692001
In Commercial Distribution

  • 10380656920011 ()
  • 00380656920014 ()

  • Length: 6 Inch


  • Nylon suture, non-bioabsorbable, monofilament

A.C.S® (Alcon Closure System) - 00380656919018

Suture - Needle Type AU-5,Black Monofilament Nylon(BMN), Suture Size 8-0, Suture Length 12,Double Armed
Alcon Laboratories, Inc.
8065691901
Not in Commercial Distribution

  • 10380656919015 ()
  • 00380656919018 ()

  • Length: 12 Inch


  • Nylon suture, non-bioabsorbable, monofilament

SILIKON™ - 00380656011873

SILIKON™ 1000 (purified polydimethylsiloxane) is highly purified long chain polydimethylsiloxane trimethylsiloxy terminated silicone oil. It is sterile, non-pyrogenic, clear, colorless and has a viscosity of 1000 cs. for use as a post-operative retinal tamponade during vitreoretinal surgery. SILIKON™ 1000 is composed of silicon, oxygen, carbon and hydrogen atoms. SILIKON™ 1000 is immiscible with aqueous components and is relatively inert material with little biological toxicity potential.
Alcon Laboratories, Inc.
8065601187
In Commercial Distribution

  • 00380656011873 ()

  • Total Volume: 8.5 Milliliter


  • Aqueous/vitreous humour replacement medium kit

SILIKON - 00380656011859

SILIKON 1000 8.5ML VIAL Purified polydimethylsiloxane
Alcon Laboratories, Inc.
8065601185
Not in Commercial Distribution

  • 00380656011859 ()
  • 10380656011856 ()

  • Total Volume: 8.5 Milliliter
8065601185

  • Aqueous/vitreous humour replacement medium kit

ACRYSOF® IQ RESTOR® - 00380655101315

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101315 ()

  • Diopter 30


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101308

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101308 ()

  • Diopter 29.5


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101292

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101292 ()

  • Diopter 29


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101285

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101285 ()

  • Diopter 28.5


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101278

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101278 ()

  • Diopter 28


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101261

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101261 ()

  • Diopter 27.5


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101254

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101254 ()

  • Diopter 27


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101247

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101247 ()

  • Diopter 26.5


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101230

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101230 ()

  • Diopter 26


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101223

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101223 ()

  • Diopter 25.5


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101216

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101216 ()

  • Diopter 25


  • Posterior-chamber intraocular lens, pseudophakic

ACRYSOF® IQ RESTOR® - 00380655101209

AcrySof(R) ReSTOR(R) APODIZED DIFFRACTIVEASPHERIC SINGLE-PIECE IOL, 13.0mm LENGTH,6.0mm OPTIC, PLANAR HAPTICS.
Alcon Laboratories, Inc.
SN6AD3
Not in Commercial Distribution

  • 00380655101209 ()

  • Diopter 24.5


  • Posterior-chamber intraocular lens, pseudophakic
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