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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 0.350 mm - 00850048576216

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-350-150
In Commercial Distribution

  • 00850048576216 ()
11700-350-150

  • Intracorneal ring segment
  • Intracorneal ring

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

AvertD™ (96) PE Mix - 10850009370249

The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-6560-01
In Commercial Distribution

  • 30850009370243 ()
  • 10850009370249 ()
03-6560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
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