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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 for Myopia, Symmetric 0.300 mm - 00850048576209

Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the correction of myopia without interfering with the patient’s central visual axis. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.250 to 0.350 mm.
ADDITION TECHNOLOGY, INC.
ICI-300-150
In Commercial Distribution

  • 00850048576209 ()
11700-300-150

  • Intracorneal ring segment
  • Intracorneal ring

Intacs for Myopia, Symmetric 0.250 mm - 00850048576193

Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the correction of myopia without interfering with the patient’s central visual axis. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.250 to 0.350 mm.
ADDITION TECHNOLOGY, INC.
ICI-250-150
In Commercial Distribution

  • 00850048576193 ()
11700-250-150

  • Intracorneal ring segment
  • Intracorneal ring

Intacs for Keratoconus, Symmetric 0.450 mm - 00850048576155

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-450-150
In Commercial Distribution

  • 00850048576155 ()
11600-450-150

  • Intracorneal ring segment
  • Intracorneal ring

Intacs for Keratoconus, Symmetric 0.400 mm - 00850048576148

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 for Keratoconus, Symmetric 0.350 mm - 00850048576131

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 for Keratoconus, Symmetric 0.300 mm - 00850048576124

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 for Keratoconus, Symmetric 0.250 mm - 00850048576117

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 for Keratoconus, Symmetric 0.210 mm - 00850048576100

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

ISPAN - 00380657970025

ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 22,200. Residual ISPAN* SF6 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797002
In Commercial Distribution

  • 00380657970025 ()

  • Weight: 125 Gram


  • Vitreous/aqueous humour replacement medium, intraoperative

ISPAN - 00380657970018

ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 22,200. Residual ISPAN* SF6 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances.
Alcon Laboratories, Inc.
8065797001
Not in Commercial Distribution

  • 00380657970018 ()

  • Weight: 450 Gram
8065797001

  • Vitreous/aqueous humour replacement medium, intraoperative
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