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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UNITY Cataract FMS Pack, 45° Hybrid Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003423
In Commercial Distribution

  • 10380650003420 ()
  • 00380650003423 ()
8065000342

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY Cataract FMS Pack, 30° Hybrid Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003416
In Commercial Distribution

  • 10380650003413 ()
  • 00380650003416 ()
8065000341

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY Cataract FMS Pack, 45° Balanced Tip with Ultra Infusion Sleeves
Alcon Laboratories, Inc.
00380650003409
In Commercial Distribution

  • 10380650003406 ()
  • 00380650003409 ()
8065000340

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY Cataract FMS Pack, 30° Hybrid Tip with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003379
In Commercial Distribution

  • 10380650003376 ()
  • 00380650003379 ()
8065000337

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY Cataract FMS Pack, 30° Balanced Tip with Micro Infusion Sleeves
Alcon Laboratories, Inc.
00380650003355
In Commercial Distribution

  • 10380650003352 ()
  • 00380650003355 ()
8065000335

  • Ophthalmic surgical procedure kit, non-medicated, single-use
25+ UNITY TOTALPLUS Posterior Pack, UES Short, UltraVit 10K Short, STD
Alcon Laboratories, Inc.
00380650003324
In Commercial Distribution

  • 10380650003321 ()
  • 00380650003324 ()
8065000332

  • Ophthalmic surgical procedure kit, non-medicated, single-use
25+ UNITY TOTALPLUS™ Posterior Pack, CVS ES UltraVit™ 10K, Straight
Alcon Laboratories, Inc.
00380650003300
In Commercial Distribution

  • 10380650003307 ()
  • 00380650003300 ()
8065000330

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY Cataract FMS Pack, Tipless with Nano Infusion Sleeves
Alcon Laboratories, Inc.
00380650003232
In Commercial Distribution

  • 10380650003239 ()
  • 00380650003232 ()
8065000323

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY Cataract FMS Pack, Basic
Alcon Laboratories, Inc.
00380650003201
In Commercial Distribution

  • 10380650003208 ()
  • 00380650003201 ()
8065000320

  • Ophthalmic surgical procedure kit, non-medicated, single-use
UNITY VCS System (Anterior/Posterior)
Alcon Laboratories, Inc.
00380650002969
In Commercial Distribution

  • 00380650002969 ()
806500296

  • Phacoemulsification/vitrectomy system
22GA Fragmentation Pack
Alcon Laboratories, Inc.
00380650001252
In Commercial Distribution

  • 10380650001259 ()
  • 00380650001252 ()

  • 22 Gauge
8065000125

  • Ophthalmic surgical procedure kit, non-medicated, single-use
Microsurgical Camera
Alcon Laboratories, Inc.
00380650001139
In Commercial Distribution

  • 00380650001139 ()


  • Microscope video camera
STAND ALONE PATIENT BED
Alcon Laboratories, Inc.
8065000110
In Commercial Distribution

  • 00380650001108 ()


  • Ophthalmic chair, line-powered
27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak
Alcon Laboratories, Inc.
8065000096
In Commercial Distribution

  • 10380650000962 ()
  • 00380650000965 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak
Alcon Laboratories, Inc.
8065000095
In Commercial Distribution

  • 10380650000955 ()
  • 00380650000958 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
LENSXPATIENT INTERFACE FLAP 10PK,EO
Alcon Laboratories, Inc.
8065000057
In Commercial Distribution

  • 10380650000573 ()
  • 00380650000576 ()


  • Ophthalmic laser system eyeball positioning suction cup
LENSX SOFTFIT PATIENT INTERFACEI FLAT,EO
Alcon Laboratories, Inc.
8065000056
In Commercial Distribution

  • 20380650000563 ()
  • 00380650000569 ()


  • Ophthalmic laser system eyeball positioning suction cup
LENSX SOFTFIT PATIENT INTERFACE STEEP,EO
Alcon Laboratories, Inc.
8065000055
In Commercial Distribution

  • 20380650000556 ()
  • 00380650000552 ()


  • Ophthalmic laser system eyeball positioning suction cup
LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
Alcon Laboratories, Inc.
8065000054
In Commercial Distribution

  • 20380650000549 ()
  • 00380650000545 ()


  • Ophthalmic laser system eyeball positioning suction cup
25+™ Short UltraVit™ 10k Probe
Alcon Laboratories, Inc.
00380650000187
In Commercial Distribution

  • 10380650000184 ()
  • 00380650000187 ()
8065000018

  • Vitrectomy system micro-cutting unit
AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249669 ()

  • Diopter 8.5
SN6AT3.085

  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249645 ()

  • Diopter 7.5
SN6AT3.075

  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249638 ()

  • Diopter 7
SN6AT3.070

  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249621 ()

  • Diopter 6.5
SN6AT3.065

  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER.
Alcon Laboratories, Inc.
SN6AT3
In Commercial Distribution

  • 00380652249614 ()

  • Diopter 6
SN6AT3.060

  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249607 ()

  • Diopter 9.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249591 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249584 ()

  • Diopter 8.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249577 ()

  • Diopter 8


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249560 ()

  • Diopter 7.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249553 ()

  • Diopter 7


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249546 ()

  • Diopter 6.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249539 ()

  • Diopter 6


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249522 ()

  • Diopter 9.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249515 ()

  • Diopter 9


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249508 ()

  • Diopter 8.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249492 ()

  • Diopter 8


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249485 ()

  • Diopter 7.5


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249478 ()

  • Diopter 7


  • Posterior-chamber intraocular lens, pseudophakic
AcrySof(R) IQ ReSTOR(R) MULTIFOCAL IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm APODIZEDDIFFRACTIVE ASPHERIC OPTIC.
Alcon Laboratories, Inc.
SN6AD1
Not in Commercial Distribution

  • 00380652249461 ()

  • Diopter 6.5


  • Posterior-chamber intraocular lens, pseudophakic
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