Address:Neuendorfstr. 23b,Hennigsdorf Brandenburg,DE
Device Description : Sinus Balloon Dilation system as set including Balloon dilation device, Inflat Sinus Balloon Dilation system as set including Balloon dilation device, Inflation device, light-confirmation device
Device Class : 1
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product MapperFrame supports the Automatic Registration process for image gu The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System.The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation headrest is mounted on the OR table instead of the original headr The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation headrest is mounted on the OR table instead of the original headr The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, which creates an electromagnetic field above the cushion of the Navigation headrest.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation headrest is mounted on the OR table instead of the original headr The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.The navigation headrest Universal comes with the following adapters:1) Adapters for siderails2)Adapters for Mizuho/Skytron Tables3)Adapters for Maquet Tables4)Adapters for Steris table5)Adapters for Eschmann Tables6)Flexarm adapters for for navigation sensor
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation headrest is mounted on the procedurechairs instead It comprises The Navigation headrest is mounted on the procedurechairs instead It comprises a holder for a Navigatin sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.The navigation headrest Office comes with the following adapters:1) Chair Adapter A2) Chair Adapter B3) Chair Adapter C4) Chair Adapter D5) Chair Adapter E6) Chair Adapter F7) Chair Adapter R
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Navigation headrest is mounted on the OR table instead of the original headr The Navigation headrest is mounted on the OR table instead of the original headrest. It comprises of a sensor, whichcreates an electromagnetic field above the cushion of the Navigation headrest.
Device Class : 2
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Fiagon Navigation System is intended as an aid for precisely locating anatom The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device 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, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomyThis also comprises of accessories 1) Extension cable instrument 2) Extension Cable localizer 3) FootSwitch 4) Double Instrument support 5) PC mouse 6) Service Keyboard 7)DVI monitor cable 8) VGA monitor cable 9)Monitor cable control 10) HDMI monitor cable 11) Composite video Cable 12) Power Cable (US)
Device Class :
Duns Number: 312623008
Premarket Exempt : No
Prescription Use : Yes