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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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LenSx, Alcon - 10380659982252

LENSX LASER SOFTFIT PATIENT
Alcon Laboratories, Inc.
8065998225
In Commercial Distribution

  • 10380659982252 ()
  • 20380659982259 ()
  • 00380659982255 ()


  • Ophthalmic laser system eyeball positioning suction cup

ML7040 (Plus 20) - 00850724001247

Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome
MED LOGICS INC
ML7040 (+20)
In Commercial Distribution

  • 10850724001244 ()
  • 00850724001247 ()
ML7040 (+20)

  • Keratome blade, single-use

ML7040 (Plano) - 00850724001148

Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome
MED LOGICS INC
ML7040 (0)
In Commercial Distribution

  • 10850724001145 ()
  • 00850724001148 ()
ML7040 (0)

  • Keratome blade, single-use

ML7040 (Minus 20) - 00850724001049

Sterile Disposable microkeratome blade, for use on the Alcon SKBM Microkeratome
MED LOGICS INC
ML7040 (-20)
In Commercial Distribution

  • 10850724001046 ()
  • 00850724001049 ()
ML7040 (-20)

  • Keratome blade, single-use

27ga One Piece Flexible Curved Laser Probe, Alcon - 00817489020418

Box of 10, 27ga One Piece Flexible Curved Laser Probe, Alcon
KATALYST SURGICAL LLC
V6111-27B
In Commercial Distribution

  • 00817489020418 ()


  • Ophthalmic fibreoptic light instrument, single-use

25ga One Piece Flexible Curved Laser Probe, Alcon - 00817489020364

Box of 10, 25ga One Piece Flexible Curved Laser Probe, Alcon
KATALYST SURGICAL LLC
V6111-25B
In Commercial Distribution

  • 00817489020364 ()


  • Ophthalmic fibreoptic light instrument, single-use

23ga One Piece Flexible Curved Laser Probe, Alcon - 00817489020319

Box of 10, 23ga One Piece Flexible Curved Laser Probe, Alcon
KATALYST SURGICAL LLC
V6111-23B
In Commercial Distribution

  • 00817489020319 ()


  • Ophthalmic fibreoptic light instrument, single-use

Synergetics - 20841305107469

25ga Awh Chandelier, Alcon® and MID Labs® Cannula Compatible
SYNERGETICS USA, INC.
56.51.25P
In Commercial Distribution

  • 20841305107469 ()
  • 10841305100982 ()
56.51.25P

  • Ophthalmic fibreoptic light instrument, single-use

MSI Precision Specialty Instruments - 00194613034368

DK Phaco Wrench for Use With Alcon Fitting Needles. Titanium Round Knurled
Med Saver, Inc.
8-001
In Commercial Distribution

  • 00194613034368 ()


  • Surgical torque wrench, reusable

Hayden Medical - 00840319715550

IOL Loading Forceps, 4-3/8", for controlled handling of IOL's, Titanium (ALCON Style)
Hayden Medical, Inc.
E5-5601T
In Commercial Distribution

  • 00840319715550 ()
E5-5601T

  • Ophthalmic implant handling forceps, reusable

Hayden Medical - 00840319715543

IOL Loading Forceps, 4-3/8", for controlled handling of IOL's stainless steel (ALCON Style)
Hayden Medical, Inc.
E5-5601
In Commercial Distribution

  • 00840319715543 ()
E5-5601

  • Ophthalmic implant handling forceps, reusable

Alcon AcrySof® - 00380659909467

AcrySof® IQ Toric IOL Calculator
Alcon Laboratories, Inc.
Version 3
In Commercial Distribution

  • 00380659909467 ()


  • Intraocular lens calculation software

THE BULLET, Alcon - 00380651092198

The BULLET Shielded Endo Illuminator Pick, Wide Angle Tip, 2.1m
Alcon Laboratories, Inc.
8065109219
Not in Commercial Distribution

  • 10380651092195 ()
  • 00380651092198 ()

  • Length: 2.1 Meter


  • Fibreoptic operating light system

THE BULLET, Alcon - 00380651092037

The BULLET Shielded Endo Illuminator, Wide Angle Tip, 20Ga, 2.1m
Alcon Laboratories, Inc.
8065109203
Not in Commercial Distribution

  • 10380651092034 ()
  • 00380651092037 ()

  • 20 Gauge
  • Length: 2.1 Meter


  • Fibreoptic operating light system

Alcon, Centurion, Ultravit - 00380657521340

Centurion Ultravit Anterior Vitrectomy Probe
Alcon Laboratories, Inc.
8065752134
In Commercial Distribution

  • 10380657521347 ()
  • 00380657521340 ()

  • 23 Gauge


  • Vitrectomy system handpiece

Alcon, Infiniti, Intrepid - 00380657520961

0.9 mm 45° Kelman® Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065752096
In Commercial Distribution

  • 10380657520968 ()
  • 00380657520961 ()

  • Outer Diameter: 0.9 Millimeter


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

Alcon, Infiniti, Intrepid - 00380657520954

0.9 mm 30° Kelman® Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065752095
In Commercial Distribution

  • 10380657520951 ()
  • 00380657520954 ()

  • Outer Diameter: 1.1 Millimeter


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

Alcon, Infiniti, Intrepid - 00380657520947

0.9 mm 45° OZil® 12 Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065752094
In Commercial Distribution

  • 10380657520944 ()
  • 00380657520947 ()


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

Alcon, Infiniti, Intrepid - 00380657520930

0.9 mm 30° OZil® 12 Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065752093
In Commercial Distribution

  • 10380657520937 ()
  • 00380657520930 ()


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

Alcon, Infiniti, Intrepid - 00380657520886

0.9 mm Tipless
Alcon Laboratories, Inc.
8065752088
In Commercial Distribution

  • 10380657520883 ()
  • 00380657520886 ()

  • Outer Diameter: 1.1 Millimeter
  • Angle: 30 degree


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

Alcon, Infiniti, Intrepid - 00380657520879

0.9 mm 45° Kelman® Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065752087
In Commercial Distribution

  • 10380657520876 ()
  • 00380657520879 ()

  • Angle: 45 degree
  • Outer Diameter: 1.1 Millimeter


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

Alcon, Infiniti, Intrepid - 00380657520862

0.9 mm 30° Kelman® Mini-Flared ABS® Tip
Alcon Laboratories, Inc.
8065752086
In Commercial Distribution

  • 10380657520869 ()
  • 00380657520862 ()

  • Angle: 30 degree
  • Outer Diameter: 1.1 Millimeter


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

Alcon, Infiniti, Intrepid - 00380657520824

Basic Ultrasound
Alcon Laboratories, Inc.
8065752082
In Commercial Distribution

  • 10380657520821 ()
  • 00380657520824 ()

  • Angle: 30 degree
  • Outer Diameter: 0.9 Millimeter


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

Alcon, Infiniti, Intrepid - 00380657517169

0.9mm Tipless
Alcon Laboratories, Inc.
8065751716
Not in Commercial Distribution

  • 10380657517166 ()
  • 00380657517169 ()


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

Eyelite, PurePoint, Alcon - 00380655002018

Eyelite/PurePoint Eye Safety Filter
Alcon Laboratories, Inc.
8065-5002-01
In Commercial Distribution

  • 00380655002018 ()


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

Alcon Single-Piece PMMA - 00380652540919

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
Alcon Laboratories, Inc.
TYPE01
Not in Commercial Distribution

  • 00380652540919 ()

  • Diopter 30
TYPE01.300

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA - 00380652540902

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
Alcon Laboratories, Inc.
TYPE01
Not in Commercial Distribution

  • 00380652540902 ()

  • Diopter 29
TYPE01.290

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA - 00380652540896

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
Alcon Laboratories, Inc.
TYPE01
Not in Commercial Distribution

  • 00380652540896 ()

  • Diopter 28
TYPE01.280

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA - 00380652540889

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
Alcon Laboratories, Inc.
TYPE01
Not in Commercial Distribution

  • 00380652540889 ()

  • Diopter 27
TYPE01.270

  • Posterior-chamber intraocular lens, pseudophakic

Alcon Single-Piece PMMA - 00380652540872

SINGLE-PIECE PMMA STERILE PCL (IOL/PC),13.5mm LENGTH, 6.0mm BICONVEX OPTIC,10-DEGREE HAPTICS.
Alcon Laboratories, Inc.
TYPE01
Not in Commercial Distribution

  • 00380652540872 ()

  • Diopter 26
TYPE01.260

  • Posterior-chamber intraocular lens, pseudophakic
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