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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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Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-400-150
In Commercial Distribution

  • 00850048576148 ()
11600-400-150

  • Intracorneal ring segment
  • Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-350-150
In Commercial Distribution

  • 00850048576131 ()
11600-350-150

  • Intracorneal ring segment
  • Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-300-150
In Commercial Distribution

  • 00850048576124 ()
11600-300-150

  • Intracorneal ring segment
  • Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-250-150
In Commercial Distribution

  • 00850048576117 ()
11600-250-150

  • Intracorneal ring segment
  • Intracorneal ring
Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI-210-150
In Commercial Distribution

  • 00850048576100 ()
11600-210-150

  • Intracorneal ring segment
  • Intracorneal ring
HercepTest for Automated Link Platforms
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK001
In Commercial Distribution

  • 05700572032007 ()

  • 50 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
HercepTest for the Dako Autostainer
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5207
Not in Commercial Distribution

  • 05700572031994 ()

  • 50 Tests


  • Human epidermal growth factor receptor 2 (HER2) protein IVD, kit, enzyme immunohistochemistry
No Description
Advanced Bionics, LLC
CI-4340
Not in Commercial Distribution

  • 07630016837128 ()
  • 07630016809941 ()


  • Cochlear implant system
No Description
Advanced Bionics, LLC
CI-4330
Not in Commercial Distribution

  • 07630016837135 ()
  • 07630016809934 ()


  • Cochlear implant system
No Description
Advanced Bionics, LLC
CI-4330
In Commercial Distribution

  • 07630016837135 ()
  • 00840094406520 ()
  • 07630016809934 ()


  • Cochlear implant system
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