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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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The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M85
Not in Commercial Distribution

  • M27240M851 ()
  • 10381780035312 ()

  • 24 platinum contacts


  • Cortical electrode
The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M84
Not in Commercial Distribution

  • M27240M841 ()
  • 10381780035305 ()

  • 24 platinum contacts


  • Cortical electrode
This is a medical device.
KaVo Dental GmbH
0.571.5621
In Commercial Distribution

  • EKAV057156210 ()
rootplaner Tip No 24

  • Ultrasonic dental scaling/debridement system
No Description
Axiodent Inc.
28019
In Commercial Distribution

  • D161280190 ()


  • Denture trial fabrication wax
No Description
CAPTIVA SPINE, INC.
CP30024
In Commercial Distribution

  • M739CP300240 ()


  • Spinal fixation plate, non-bioabsorbable
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301124-000
In Commercial Distribution

  • B0663011240000 ()
  • B0663011240006 ()
301124-000

  • Cardiopulmonary bypass system priming set
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Dental Direkt GmbH
24x24x24 D4
In Commercial Distribution

  • EDDI32773024241 ()

  • Length: 24 Millimeter
  • Height: 24 Millimeter
  • Width: 24 Millimeter
3277302424

  • Dental appliance fabrication material, ceramic
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Dental Direkt GmbH
24x24x24 D3
In Commercial Distribution

  • EDDI32763024241 ()

  • Length: 24 Millimeter
  • Height: 24 Millimeter
  • Width: 24 Millimeter
3276302424

  • Dental appliance fabrication material, ceramic
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Dental Direkt GmbH
24x24x24 D2
In Commercial Distribution

  • EDDI32753024241 ()

  • Length: 24 Millimeter
  • Height: 24 Millimeter
  • Width: 24 Millimeter
3275302424

  • Dental appliance fabrication material, ceramic
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Dental Direkt GmbH
24x24x24 C4
In Commercial Distribution

  • EDDI32743024241 ()

  • Length: 24 Millimeter
  • Height: 24 Millimeter
  • Width: 24 Millimeter
3274302424

  • Dental appliance fabrication material, ceramic
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