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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 Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE011103CUS1 ()


  • Multi-purpose stereotactic surgery system
The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0110091 ()

  • Weight: 9.3 Kilogram
  • Height: 160 Millimeter
  • Width: 260 Millimeter
  • Length: 500 Millimeter


  • Multi-purpose stereotactic surgery system
The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest. The navigation headrest Universal comes with the following adapters: 1) Adapters for siderails 2)Adapters for Mizuho/Skytron Tables 3)Adapters for Maquet Tables 4)Adapters for Steris table 5)Adapters for Eschmann Tables 6)Flexarm adapters for for navigation sensor
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0110031 ()

  • Weight: 9.6 Kilogram
  • Height: 120 Millimeter
  • Width: 300 Millimeter
  • Length: 550 Millimeter


  • Multi-purpose stereotactic surgery system
The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0110021 ()

  • Weight: 10.2 Kilogram
  • Height: 120 Millimeter
  • Width: 280 Millimeter
  • Length: 580 Millimeter


  • Multi-purpose stereotactic surgery system
The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0110011 ()

  • Height: 180 Millimeter
  • Width: 320 Millimeter
  • Length: 475 Millimeter
  • Weight: 9.6 Kilogram


  • Multi-purpose stereotactic surgery system
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030010 ()
  • EFIAE0030011 ()
  • 04260759931512 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram
E 00 3001

  • Multi-purpose stereotactic surgery system
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030001 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram


  • Multi-purpose stereotactic surgery system
The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System. The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAA0127041 ()


  • Multi-purpose stereotactic surgery system
The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-400-00
In Commercial Distribution

  • B815SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
DI-400-00
In Commercial Distribution

  • B815DI400000 ()
DI-400-00

  • Haemodialysis blood tubing set, single-use
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