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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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FlexPointer 1.5 Cranial - EFIAE012004CUS1

The products FlexPointer 1.5 Cranial is a product variant of a navigated pointer probe for image guided surgical procedures The instruments are accessories to the Fiagon Navigation system. The 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

  • EFIAE012004CUS0 ()
  • EFIAE012004CUS1 ()


  • Multi-purpose stereotactic surgery system

FlexPointer 1.5 Cranial - EFIAE012004CUS

The products FlexPointer 1.5 Cranial is a product variant of a navigated pointer probe for image guided surgical procedures The instruments are accessories to the Fiagon Navigation system. The 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
In Commercial Distribution

  • EFIAE012004CUS ()


  • Multi-purpose stereotactic surgery system

FlexPointer 1.5 - EFIAE0120041

The product FlexPointer 1.5 are product variants of a navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are 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 ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0120041 ()
  • EFIAE0120040 ()


  • Multi-purpose stereotactic surgery system

RegistrationPointer Cranial - EFIAE012003CUS1

The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The RegistrationPointert Cranial is designed to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigation system produced by fiagon GmbH. The instrument is accessories to the Fiagon Navigation system. The 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

  • EFIAE012003CUS1 ()
  • EFIAE012003CUS0 ()


  • Multi-purpose stereotactic surgery system

RegistrationPointer - EFIAE0120031

The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guided surgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which is designed to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigation system produced by Fiagon GmbH. The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation – Extended Instrument Set ENT 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 ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0120031 ()
  • EFIAE0120030 ()


  • Multi-purpose stereotactic surgery system

FlexPointer Cranial - EFIAE012002CUS1

The products FlexPointer Cranial is a product variants of a navigated pointer probe for image guided surgical procedures The instruments are accessories to the Fiagon Navigation system. The 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

  • EFIAE012002CUS1 ()
  • EFIAE012002CUS0 ()


  • Multi-purpose stereotactic surgery system

FlexPointer - EFIAE0120021

The product FlexPointer are product variants of a navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are 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 ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0120021 ()
  • EFIAE0120020 ()

  • Shaft: 2.8 X 180mm
  • Weight: 0.045 Kilogram
  • Handle 10mmX12mm


  • Multi-purpose stereotactic surgery system

Fiagon Navigation Unit - EFIAE0111060

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device 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 ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy This also comprises of accessories 1) Extension cable instrument 2) Multi Instrument support 3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US)
Fiagon GmbH
CUBE4D
Not in Commercial Distribution

  • EFIAE0111060 ()


  • Multi-purpose stereotactic surgery system

Fiagon Navigation Unit Cranial - EFIAE011103CUS1

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

Navigation Headrest Trumpf - EFIAE0110091

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
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