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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 productPointerShell Universal is a product variant for the navigation of shavers or surgical instruments without motor in the handleThey 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

  • EFIAE0129041 ()
  • EFIAE0129040 ()


  • Multi-purpose stereotactic surgery system
The products PointerShell 3mm is a product variants for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ‘PointerShells’ below. 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

  • EFIAE0129021 ()
  • EFIAE0129020 ()


  • Multi-purpose stereotactic surgery system
The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ,PointerShell. 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

  • EFIAE0129011 ()
  • EFIAE0129010 ()


  • Multi-purpose stereotactic surgery system
The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ‘PointerShells’ below. 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

  • EFIAE0129001 ()
  • EFIAE0129000 ()


  • Multi-purpose stereotactic surgery system
The products FinePointer 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

  • EFIAE012300CUS1 ()
  • EFIAE012300CUS0 ()


  • Multi-purpose stereotactic surgery system
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
Ultrasonic led scaler handpiece
MECTRON SPA
LED SCALER HANDPIECE
In Commercial Distribution

  • E322031201420010 ()
03120142-001

  • Ultrasonic dental scaling/debridement system handpiece
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