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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 product FinePointer 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

  • EFIAE0123001 ()
  • EFIAE0123000 ()

  • Weight: 0.045 Kilogram
  • Handle 10mmX12mm
  • Shaft 1.5mmX120mm


  • Multi-purpose stereotactic surgery system
The product Localizer Bone Anchor is a product variant of a patient reference localisator for image guided surgical procedures for cranial indications.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE01220410 ()
  • EFIAE0122041 ()


  • Multi-purpose stereotactic surgery system
The product Localizer Adhesive pad Cranial is a product variant of a patient reference localisator for image guided surgical procedures. The adhesive pad is an accessory of the Localizer Adhesive Pad.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE012202CUS1 ()
  • EFIAE012202CUS0 ()


  • Multi-purpose stereotactic surgery system
The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. The adhesive pad is an accessory of the Localizer Adhesive pad. The model C-Type has a modified plug.
Fiagon GmbH
C-Type
Not in Commercial Distribution

  • EFIAE012202C0 ()
  • EFIAE012202C1 ()

  • Weight: 0.025 Kilogram
  • Housing 25mmX8mm


  • Multi-purpose stereotactic surgery system
The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. The adhesive pad is an important accessory of the Localizer Adhesive pad.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0122021 ()
  • EFIAE0122020 ()

  • Weight: 0.025 Kilogram
  • Housing 25mmX8mm


  • Multi-purpose stereotactic surgery system
The product Localizer Headband is a product variant of a patient reference localisator. for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid laws and regulations. An operator is everyone who uses the system. The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0122001 ()
  • EFIAE0122000 ()

  • Weight: 0.035 Kilogram
  • Height: 15 Millimeter
  • Width: 30 Millimeter
  • Length: 45 Millimeter


  • Multi-purpose stereotactic surgery system
The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument 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 instrument is indicated for any medical condition in which the use ofstereotactic 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

  • EFIAE0121081 ()
  • EFIAE0121080 ()

  • Olive tip: Ø 4,3 Millimeter
  • Outer Diameter: 3 Millimeter
  • Length: 130 Millimeter


  • Multi-purpose stereotactic surgery system
The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument 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 instrument is indicated for any medical condition in which the use ofstereotactic 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

  • EFIAE0121071 ()
  • EFIAE0121070 ()

  • Length: 100 Millimeter
  • Outer Diameter: 3 Millimeter
  • Olive tip: Ø 4,3 Millimeter


  • Multi-purpose stereotactic surgery system
The products are variants of a navigated suction instrument 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

  • EFIAE0121061 ()
  • EFIAE0121060 ()


  • Multi-purpose stereotactic surgery system
The products are variants of a navigated suction instrument 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

  • EFIAE0121041 ()
  • EFIAE0121040 ()


  • Multi-purpose stereotactic surgery system
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