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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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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

CENTURION® INTREPID® - 00380657531349

Active FMS w INTERPID Ultra Sleeves 0.9MM 30° ABS* INTERPID Hybrid Tip
Alcon Laboratories, Inc.
8065753134
In Commercial Distribution

  • 10380657531346 ()
  • 00380657531349 ()


  • 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

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380657531066

25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Vitrectomy Pak
Alcon Laboratories, Inc.
8065753106
In Commercial Distribution

  • 10380657531063 ()
  • 00380657531066 ()


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

Ngenuity - 00380657530915

Microsurgical Camera
Alcon Laboratories, Inc.
00380657530915
In Commercial Distribution

  • 00380657530915 ()


  • Microscope video camera

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 - 00380657530632

Surgical Microscope System
Alcon Laboratories, Inc.
00380657530632
Not in Commercial Distribution

  • 00380657530632 ()


  • Ophthalmic surgical microscope

LuxOR - 00380657530625

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

  • 00380657530625 ()


  • Ophthalmic surgical microscope
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