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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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LuxOR Revalia - 00380657530724

Surgical Microscope
Alcon Laboratories, Inc.
00380657530724
In Commercial Distribution

  • 00380657530724 ()


  • Ophthalmic surgical microscope

UNIPURE & UNIPEXY - 00380657530694

UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.
Alcon Laboratories, Inc.
8065753069
In Commercial Distribution

  • 10380657530691 ()
  • 00380657530694 ()
8065753069

  • Sulfur hexafluoride refillable cylinder

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

LuxOR - 00380657530625

Surgical Microscope System
Alcon Laboratories, Inc.
00380657530625
In Commercial Distribution

  • 00380657530625 ()


  • Ophthalmic surgical microscope

ORA System® VerifEye™ - 00380657530007

ORA System with VerifEyeTM Lynk, Aberrometer 190.5
Alcon Laboratories, Inc.
8065753000
In Commercial Distribution

  • 00380657530007 ()


  • Automated ophthalmic refractometer

Purepoint - 00380657529872

Purepoint Laser
Alcon Laboratories, Inc.
8065752987
In Commercial Distribution

  • 00380657529872 ()


  • Indirect binocular laser ophthalmoscope

CENTURION® INTREPID® - 00380657529018

SMALL PARTS KIT W/ INTREPID® NANO SLEEVES 0.9 MM Tipless
Alcon Laboratories, Inc.
8065752901
In Commercial Distribution

  • 10380657529015 ()
  • 00380657529018 ()


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

LuxOR - 00380657525706

Surgical Microscope System
Alcon Laboratories, Inc.
00380657525706
In Commercial Distribution

  • 00380657525706 ()


  • Ophthalmic surgical microscope

LuxOR - 00380657525683

Surgical Microscope System
Alcon Laboratories, Inc.
00380657525683
In Commercial Distribution

  • 00380657525683 ()


  • Ophthalmic surgical microscope
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