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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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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® - 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® - 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

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

ORA System® VerifEye™ - 00380657530939

ORA System with VerifEyeTM+ 2.0, Cart
Alcon Laboratories, Inc.
8065753093
In Commercial Distribution

  • 00380657530939 ()


  • Automated ophthalmic refractometer

LuxOR Revalia - 00380657530731

Surgical Microscope
Alcon Laboratories, Inc.
00380657530731
In Commercial Distribution

  • 00380657530731 ()


  • Ophthalmic surgical microscope

LuxOR Revalia - 00380657530717

Surgical Microscope
Alcon Laboratories, Inc.
00380657530717
In Commercial Distribution

  • 00380657530717 ()


  • Ophthalmic surgical microscope

UNIPURE & UNIFEYE - 00380657530670

UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753067
In Commercial Distribution

  • 10380657530677 ()
  • 00380657530670 ()
8065753067

  • Sulfur hexafluoride refillable cylinder

LuxOR - 00380657530656

Surgical Microscope System
Alcon Laboratories, Inc.
00380657530656
In Commercial Distribution

  • 00380657530656 ()


  • Ophthalmic surgical microscope
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