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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Surgical-Osteotomy
SATELEC
CMF KIT NON-STERIL
In Commercial Distribution

  • 03609820578033 ()
F57803

  • Hard/soft-tissue ultrasonic surgical system
General surgery ultrasonic handpiece Alternative DI : 10887587025766
SATELEC
05.001.401
In Commercial Distribution

  • 03609820128184 ()
F12818

  • Hard/soft-tissue ultrasonic surgical system
The product ShuntPointer is a product variant for the navigation of neurosurgical shunt placement. 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

  • EFIAN012060CUS1 ()
  • EFIAN012060CUS0 ()


  • Multi-purpose stereotactic surgery system
The product BiopsyPointer 250 referred to as BiopsyPointer is a product variant for the navigation of neurosurgical brain biopsy cannulas. 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

  • EFIAN012051CUS1 ()
  • EFIAN012051CUS0 ()


  • Multi-purpose stereotactic surgery system
The products BiopsyPointer 190 referred to as BiopsyPointer is a product variant for the navigation of neurosurgical brain biopsy cannulas. The instruments are accessories to the Fiagon Navigation system. The instruments in connection with the Navigation system 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 cranial surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAN012050CUS1 ()
  • EFIAN012050CUS0 ()


  • Multi-purpose stereotactic surgery system
The products GuideWire 0.6 is a variant of a navigated probe for image guided surgical procedures with the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool The instruments are accessories to the Fiagon navigation system. It is designed to be used with the Fiagon Navigation system and the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool The XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by Entellus Medical Inc./USA and are registered as 510K devices with the FDA. The use is not subject of these instructions for use.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0129131 ()
  • EFIAE0129130 ()


  • Multi-purpose stereotactic surgery system
The product GuideWire is a product variant of a navigated probe for image guided surgical procedures. The GuideWire 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 GuideWire 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

  • EFIAE0129111 ()
  • EFIAE0129110 ()


  • Multi-purpose stereotactic surgery system
The product VenteraPointer is a variant of a navigated probe for image guided surgical procedures with the Ventera® Cannulated Articulating Delivery Instrument. 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 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

  • EFIAE0129101 ()
  • EFIAE0129100 ()


  • Multi-purpose stereotactic surgery system
The product PointerShell LS is a product variant for the navigation of shavers or surgical instruments without motor in the handle. The product PointerShell LS is used specially for the navigation surgical instruments with octagonal shafts with a maximum diameter of 6mm (For eg: Ostium Seeker produced by Entellus Medical Inc). 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

  • EFIAE0129061 ()
  • EFIAE0129060 ()


  • Multi-purpose stereotactic surgery system
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
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