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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 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

Intacs Corneal Implants - 00866304000104

An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. The medical device is a plastic arc, of about 150 degrees, that is inserted into the cornea via an intrastromal channel. It is typically available in sizes from 0.250 to 0.450 mm.
ADDITION TECHNOLOGY, INC.
ICI
In Commercial Distribution

  • 00866304000104 ()


  • Intracorneal ring segment
  • Intracorneal ring

Model 2200A-47E Maestro Anterior Lead - 00857334004286

The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
2200A-47E
Not in Commercial Distribution

  • 00857334004286 ()

  • Length: 47 Centimeter
2200A-47E

  • Vagus nerve electrical stimulation system lead

Model 2200P-47E Maestro Posterior Lead - 00857334004293

The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the posterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator. The Posterior Lead contains a white stripe along the lead body, a white suture tab, and a white coating on its' conductor cables to distinguish it from the Anterior Lead.
Reshape Lifesciences Inc.
2200P-47E
Not in Commercial Distribution

  • 00857334004293 ()

  • Length: 47 Centimeter
2200P-47E

  • Vagus nerve electrical stimulation system lead

HeartSine Samaritan PAD 450P - 05060167129773

Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167129773 ()
450-STR-AS-GW

  • Non-rechargeable public semi-automated external defibrillator
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