Address:Neuendorfstr. 23b,Hennigsdorf Brandenburg,DE
Device Description : The products FlexPointer 1.5 Cranial is a product variant of a navigatedpoint The products FlexPointer 1.5 Cranial is a product variant of a navigatedpointer probe for image guided surgical proceduresThe 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 beappropriate, and where reference to a rigid anatomical structure in the field of cranial surgery can be identifiedrelative to a CT or MR based model of the anatomy.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products are variants of a navigated suction instrument for image guided sur The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products are variants of a navigated suction instrument for image guided sur The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products are variants of a navigated suction instrument for image guided sur 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 percutaneousprocedures. 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 orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products are variants of a navigated suction instrument for image guided sur The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The products are variants of a navigated suction instrument for image guided sur The products are variants of a navigated suction instrument for image guided surgical proceduresThe instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is a variant of a navigated suction instrument for image guided surg 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.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is a variant of a navigated suction instrument for image guided surg 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.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product Localizer Headband is a product variant of a patient reference local 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, theusers receive a training. The operator, i.e., the person or facility that is responsible for the use and service of thesystem, must ensure that all users of the system receive an adequate introduction into the system in accordance withvalid 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 ofthe navigation system describe the proper use of the entire system in detail.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The localizer as a part of the navigation system serves as a reference fixed to The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use ofthe navigation system describe the proper use of the entire system in detail.The adhesive pad is an important accessory of the Localizer Adhesive pad.
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes