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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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RIMSA P. LONGONI SRL
Z400460-4
In Commercial Distribution

  • B880Z40046040 ()


  • Medical equipment handle cover, reusable
No Description
RIMSA P. LONGONI SRL
Z400349-4
In Commercial Distribution

  • B880Z40034940 ()


  • Medical equipment handle cover, reusable
No Description
RIMSA P. LONGONI SRL
Z400307-4
In Commercial Distribution

  • B880Z40030740 ()


  • Medical equipment handle cover, reusable
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 Navigation sensor Mayfield is a product variant of a navigation sensor which is mountable to a ‘Carbon Skull clamp’ set consisting of the third party product Integra Mayfield Infinity XR2 Skull Clamp (A2114) mounted to the OR table using the third party product Integra Mayfield Ultra Base Unit (A-2101) and is referred to as ‘base unit’ below. The navigation sensor Mayfield is to be mounted to the Carbon Skull clamp, to create an electromagnetic field in the surgical area. It will enable the usage of the fiagon navigation system during neurological surgeries.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAN011004MF1 ()


  • Multi-purpose stereotactic surgery system
The product GuideWire 0.6 Singel Use 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 instrument is an accessory to the Fiagon navigation system. It is designed to be used with the Fiagon Navigation system and with 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. These are not subject of this instructions for use.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0139131 ()

  • Length: 278 Millimeter
  • Outer Diameter: 0.6 Millimeter


  • 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
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