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 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

  • EFIAE0121011 ()
  • EFIAE0121010 ()


  • Multi-purpose stereotactic surgery system
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
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
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
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
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
Surgical-Osteotomy
SATELEC
TKW2 II TIP N STER
In Commercial Distribution

  • 03609820876429 ()
F87679

  • Hard/soft-tissue ultrasonic surgical system
Surgical-Osteotomy
SATELEC
TKW1 II TIP N STER
In Commercial Distribution

  • 03609820876412 ()
F87641

  • Hard/soft-tissue ultrasonic surgical system
Surgical-Expansion
SATELEC
CS6 M+ TIP N STER
In Commercial Distribution

  • 03609820876344 ()
F87634

  • Hard/soft-tissue ultrasonic surgical system
Surgical-Expansion
SATELEC
CS5 M+ TIP N STER
In Commercial Distribution

  • 03609820876337 ()
F87633

  • Hard/soft-tissue ultrasonic surgical system
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