Other products from "FIAGON GMBH"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 EFIAE0030001 1 HAW Neurological Stereotaxic Instrument 2 Headband
2 EFIAE0129021 1 The products PointerShell 3mm is a product variants for the navigation of shaver The products PointerShell 3mm is a product variants for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below.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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerShell 3 mm
3 EFIAE0129011 1 The product, PointerShell 5 mm is a product variant for the navigation of shave The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle andare referred to as ,PointerShell.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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerShell 5 mm
4 EFIAE012202CUS1 1 The product Localizer Adhesive pad Cranial is a product variant of a patient ref The product Localizer Adhesive pad Cranial is a product variant of a patient reference localisator for image guidedsurgical procedures. The adhesive pad is an accessory of the Localizer Adhesive Pad. HAW Neurological Stereotaxic Instrument Localizer Adhesive pad Cranial
5 EFIAE0121081 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerTube Kennedy
6 EFIAE0121031 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerTube Sinus Frontalis
7 EFIAE0114301 v2 E 01 1430 Accessory to Cube navigation systems. Device for registration. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 VirtuEye
8 EFIAE0110091 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Navigation Headrest Trumpf
9 EFIAE0130041 1 E 01 3004 The product FlexPointer 1.5 single use is navigated pointer probe for image guid The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FlexPointer 1.5 single use
10 EFIAE0129111 1 The product GuideWire is a product variant of a navigated probe for image guided 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 percutaneousprocedures. 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 orMR based model of the anatomy. PGW Ear, Nose, And Throat Stereotaxic Instrument Guidewire
11 EFIAE0129101 1 The product VenteraPointer is a variant of a navigated probe for image guided su The product VenteraPointer is a variant of a navigated probe for image guided surgical procedures with theVentera® Cannulated Articulating Delivery Instrument.The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy. PGW Ear, Nose, And Throat Stereotaxic Instrument VenteraPointer
12 EFIAE012202C1 C-Type 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 accessory of the Localizer Adhesive pad.The model C-Type has a modified plug. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Localizer Adhesive pad
13 EFIAE0122021 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument Localizer Adhesive pad
14 EFIAE0122001 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument Localizer Headband
15 EFIAE0120041 1 The product FlexPointer 1.5 are product variants of a navigatedpointer probe fo The product FlexPointer 1.5 are product variants of a navigatedpointer probe 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FlexPointer 1.5
16 EFIAE0110011 1 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. HAW,PGW Neurological Stereotaxic Instrument,Ear, Nose, And Throat Stereotaxic Instrument 2 Navigation Headrest Flat
17 04260759931253 1 E 01 3536 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 LCR Fluorescent Immunoassay, Tobramycin 1 VenSure Light Balloon Dilation System
18 EFIAE0131041 1 The product is a single use navigated suction instrument for image guided surgic The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FlexTube 3 single use
19 EFIAE0129061 1 The product PointerShell LS is a product variant for the navigation of shavers o 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 withoctagonal 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 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerShell LS
20 EFIAE012003CUS1 1 The product RegistrationPointer Cranial is a navigated pointer probe for perform The product RegistrationPointer Cranial is a navigated pointer probe for performing non-steril registration for imageguided surgical procedures. The RegistrationPointert Cranial is designed to be used with the Fiagon Navigationsystem. The instrument is an accessory to the Fiagon Navigation system produced by fiagon GmbH.The instrument is 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. HAW Neurological Stereotaxic Instrument RegistrationPointer Cranial
21 EFIAE0114201 1 E 01 1420 Accessory to Fiagon navigation systems. Device for registration. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 VirtuEye V1
22 EFIAE0135921 1 E 01 3592 Inflation device for Vensure Balloon Dilation System LRC Instrument, Ent Manual Surgical 1 Vensure Inflation Device
23 EFIAE0135161 1 LRC Instrument, Ent Manual Surgical 1 VenSure Nav Balloon Sinus Dilation System
24 EFIAE0129131 1 The products GuideWire 0.6 is a variant of a navigated probe for image guided su The products GuideWire 0.6 is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation ToolThe instruments are accessories to the Fiagon navigation system. It is designed to be used with the FiagonNavigation system and the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation ToolThe XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by EntellusMedical Inc./USA and are registered as 510K devices with the FDA. The use is not subject of these instructions foruse. PGW Ear, Nose, And Throat Stereotaxic Instrument Guidewire 0.6
25 EFIAE012004CUS1 1 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. HAW Neurological Stereotaxic Instrument 2 FlexPointer 1.5 Cranial
26 EFIAE012004CUS 1 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. HAW Neurological Stereotaxic Instrument 2 FlexPointer 1.5 Cranial
27 EFIAE0110081 1 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 PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Navigation Headrest Office
28 EFIAE0110031 1 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 HAW,PGW Neurological Stereotaxic Instrument,Ear, Nose, And Throat Stereotaxic Instrument 2 Navigation Headrest Universal
29 EFIAN012050CUS1 1 The products BiopsyPointer 190 referred to as BiopsyPointer is a product variant The products BiopsyPointer 190 referred to as BiopsyPointer is a product variant forthe 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 ofstereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of cranialsurgery can be identified relative to a CT or MR based model of the anatomy. HAW Neurological Stereotaxic Instrument BiopsyPointer 190
30 EFIAE0129041 1 The productPointerShell Universal is a product variant for the navigation of sh 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 orMR based model of the anatomy. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerShell Universal
31 EFIAE0129001 1 The product PointerShell 4 mm is a product variant for the navigation of shavers The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below. 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerShell 4 mm
32 EFIAN012060CUS1 1 The product ShuntPointer is a product variant for the navigation of neurosurgica 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 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. HAW Neurological Stereotaxic Instrument ShuntPointer
33 EFIAE012300CUS1 1 The products FinePointer Cranial is a product variant of a navigatedpointer pro The products FinePointer 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. HAW Neurological Stereotaxic Instrument FinePointer Cranial
34 EFIAE0123001 1 The product FinePointer are product variants of a navigated pointer probe forima The product FinePointer are product variants of a navigated pointer probe forimage 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FinePointer
35 EFIAE0121061 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FlexTube 4 mm
36 EFIAE0121011 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerTube Straight
37 EFIAE0120021 1 The product FlexPointer are product variants of a navigated pointer probe forima The product FlexPointer are product variants of a navigated pointer probe forimage 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FlexPointer
38 EFIAE011103CUS1 1 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 neurosurgical procedures. The Fiagon 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. HAW Neurological Stereotaxic Instrument 2 Fiagon Navigation Unit Cranial
39 EFIAA0127041 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 MapperFrame
40 EFIAN012051CUS1 1 The product BiopsyPointer 250 referred to as BiopsyPointer is a product variant The product BiopsyPointer 250 referred to as BiopsyPointer is a product variant forthe navigation of neurosurgical brain biopsy cannulas.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. HAW Neurological Stereotaxic Instrument BiopsyPointer 250
41 EFIAN011004MF1 1 The Navigation sensor Mayfield is a product variant of a navigation sensor which 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. HAW Neurological Stereotaxic Instrument 2 Navigation Sensor Mayfield
42 EFIAE0139131 1 The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile 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 FiagonNavigation 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 EntellusMedical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions foruse. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Guidewire 0.6 Single Use
43 EFIAE0135061 1 E 01 3506 LRC Instrument, Ent Manual Surgical 1 VenSure Balloon Sinus Dilation System
44 EFIAE0121041 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument FlexTube 3mm
45 EFIAE0122041 1 The product Localizer Bone Anchor is a product variant of a patient reference lo The product Localizer Bone Anchor is a product variant of a patient reference localisator for image guidedsurgical procedures for cranial indications. HAW Neurological Stereotaxic Instrument 2 Localizer Bone Anchor
46 EFIAE0121021 1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerTube Stammberger
47 EFIAE0120031 1 The products RegistrationPointer is a navigated pointer probe for performing non The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guidedsurgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which isdesigned to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigationsystem produced by Fiagon GmbH.The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system usingelectromagnetic navigation.The Fiagon Navigation – Extended Instrument Set ENT 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 ENTsurgery can be identified relative to a CT or MR based model of the anatomy. PGW Ear, Nose, And Throat Stereotaxic Instrument RegistrationPointer
48 EFIAE012002CUS1 1 The products FlexPointer Cranial is a product variants of a navigatedpointer pr The products FlexPointer Cranial is a product variants 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. HAW Neurological Stereotaxic Instrument FlexPointer Cranial
49 EFIAE0111060 CUBE4D 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) Multi Instrument support3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US) PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Fiagon Navigation Unit
50 EFIAE0111031 1 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) PGW Ear, Nose, And Throat Stereotaxic Instrument Fiagon Navigation Unit
Other products with the same Product Code "PGW"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04546540696410 7700-600-000 7700-600-000 Stryker ADAPT(R) PLATFORM STRYKER ADAPT STRYKER LEIBINGER GMBH & CO. KG
2 04048551398425 40820084 Adhesive Pad, sterile, package of 20 n.a. KARL STORZ GMBH & CO. KG
3 04048551387368 40820150 EM Endoscope Tracker, universal n.a. KARL STORZ GMBH & CO. KG
4 04048551387344 40820123 EM Shaver Tracker n.a. KARL STORZ GMBH & CO. KG
5 04048551375341 40820600 Holding Arm EM Navigation n.a. KARL STORZ GMBH & CO. KG
6 04048551347980 40820105 EM Navigation Probe n.a. KARL STORZ GMBH & CO. KG
7 04048551347966 40820112 EM Navigation Probe n.a. KARL STORZ GMBH & CO. KG
8 04048551347959 40820132 EM Frontal Sinus Curette n.a. KARL STORZ GMBH & CO. KG
9 04048551347904 40820110 EM Navigation Probe n.a. KARL STORZ GMBH & CO. KG
10 04048551347829 40820131 EM Antrum Curette n.a. KARL STORZ GMBH & CO. KG
11 04048551346594 40820165 EM Suction Tube n.a. KARL STORZ GMBH & CO. KG
12 04048551346587 40820145 EM Suction Tube n.a. KARL STORZ GMBH & CO. KG
13 04048551346570 40820130 EM Frontal Sinus Curette n.a. KARL STORZ GMBH & CO. KG
14 04048551346556 40820111 EM Frontal Sinus Probe n.a. KARL STORZ GMBH & CO. KG
15 04048551342992 40820160 EM Navigation Probe n.a. KARL STORZ GMBH & CO. KG
16 04048551342985 40820140 EM Navigation Probe n.a. KARL STORZ GMBH & CO. KG
17 04048551337820 40820030 NAV1 ELECTROMAGNETIC Field Generator NAV1 KARL STORZ GMBH & CO. KG
18 04048551337707 40820086 EM Patient Tracker n.a. KARL STORZ GMBH & CO. KG
19 04048551336854 40820020 NAV1 ELECTROMAGNETIC Module NAV1 KARL STORZ GMBH & CO. KG
20 04048551313879 40800084 Headband for Navigation, reusable n.a. KARL STORZ GMBH & CO. KG
21 EFIAE0139131 1 The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image The product GuideWire 0.6 Singel Use is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile 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 FiagonNavigation 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 EntellusMedical Inc./USA and are registered as 510K devices with the FDA. These are not subject of this instructions foruse. Guidewire 0.6 Single Use FIAGON GMBH
22 EFIAE0131041 1 The product is a single use navigated suction instrument for image guided surgic The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for 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. FlexTube 3 single use FIAGON GMBH
23 EFIAE0130041 1 E 01 3004 The product FlexPointer 1.5 single use is navigated pointer probe for image guid The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for 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. FlexPointer 1.5 single use FIAGON GMBH
24 EFIAE0129131 1 The products GuideWire 0.6 is a variant of a navigated probe for image guided su The products GuideWire 0.6 is a variant of a navigated probe for image guided surgical procedures with the XprESSLoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation ToolThe instruments are accessories to the Fiagon navigation system. It is designed to be used with the FiagonNavigation system and the XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation ToolThe XprESS LoProfile Multi-Sinus Dilation Tool and XprESS Multi-Sinus Dilation Tool are produced by EntellusMedical Inc./USA and are registered as 510K devices with the FDA. The use is not subject of these instructions foruse. Guidewire 0.6 FIAGON GMBH
25 EFIAE0129111 1 The product GuideWire is a product variant of a navigated probe for image guided 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 percutaneousprocedures. 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 orMR based model of the anatomy. Guidewire FIAGON GMBH
26 EFIAE0129101 1 The product VenteraPointer is a variant of a navigated probe for image guided su The product VenteraPointer is a variant of a navigated probe for image guided surgical procedures with theVentera® Cannulated Articulating Delivery Instrument.The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneousprocedures. 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 orMR based model of the anatomy. VenteraPointer FIAGON GMBH
27 EFIAE0129061 1 The product PointerShell LS is a product variant for the navigation of shavers o 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 withoctagonal 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 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. PointerShell LS FIAGON GMBH
28 EFIAE0129041 1 The productPointerShell Universal is a product variant for the navigation of sh 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 orMR based model of the anatomy. PointerShell Universal FIAGON GMBH
29 EFIAE0129021 1 The products PointerShell 3mm is a product variants for the navigation of shaver The products PointerShell 3mm is a product variants for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below.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. PointerShell 3 mm FIAGON GMBH
30 EFIAE0129011 1 The product, PointerShell 5 mm is a product variant for the navigation of shave The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle andare referred to as ,PointerShell.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. PointerShell 5 mm FIAGON GMBH
31 EFIAE0129001 1 The product PointerShell 4 mm is a product variant for the navigation of shavers The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referredto as ‘PointerShells’ below. 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. PointerShell 4 mm FIAGON GMBH
32 EFIAE0123001 1 The product FinePointer are product variants of a navigated pointer probe forima The product FinePointer are product variants of a navigated pointer probe forimage 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. FinePointer FIAGON GMBH
33 EFIAE012202C1 C-Type 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 accessory of the Localizer Adhesive pad.The model C-Type has a modified plug. Localizer Adhesive pad FIAGON GMBH
34 EFIAE0122021 1 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. Localizer Adhesive pad FIAGON GMBH
35 EFIAE0122001 1 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. Localizer Headband FIAGON GMBH
36 EFIAE0121081 1 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. PointerTube Kennedy FIAGON GMBH
37 EFIAE0121071 1 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. PointerTube Keat FIAGON GMBH
38 EFIAE0121061 1 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. FlexTube 4 mm FIAGON GMBH
39 EFIAE0121041 1 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. FlexTube 3mm FIAGON GMBH
40 EFIAE0121031 1 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. PointerTube Sinus Frontalis FIAGON GMBH
41 EFIAE0121021 1 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. PointerTube Stammberger FIAGON GMBH
42 EFIAE0121011 1 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. PointerTube Straight FIAGON GMBH
43 EFIAE0120041 1 The product FlexPointer 1.5 are product variants of a navigatedpointer probe fo The product FlexPointer 1.5 are product variants of a navigatedpointer probe 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. FlexPointer 1.5 FIAGON GMBH
44 EFIAE0120031 1 The products RegistrationPointer is a navigated pointer probe for performing non The products RegistrationPointer is a navigated pointer probe for performing non-steril registration for image guidedsurgical procedures. The instrument is part of the Fiagon Navigation – Extended instrument set ENT, which isdesigned to be used with the Fiagon Navigation system. The instrument is an accessory to the Fiagon Navigationsystem produced by Fiagon GmbH.The Fiagon Navigation - Extended Instrument Set ENT is intended as an aid for precisely locating anatomicalstructures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system usingelectromagnetic navigation.The Fiagon Navigation – Extended Instrument Set ENT 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 ENTsurgery can be identified relative to a CT or MR based model of the anatomy. RegistrationPointer FIAGON GMBH
45 EFIAE0120021 1 The product FlexPointer are product variants of a navigated pointer probe forima The product FlexPointer are product variants of a navigated pointer probe forimage 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. FlexPointer FIAGON GMBH
46 EFIAE0114301 v2 E 01 1430 Accessory to Cube navigation systems. Device for registration. VirtuEye FIAGON GMBH
47 EFIAE0114201 1 E 01 1420 Accessory to Fiagon navigation systems. Device for registration. VirtuEye V1 FIAGON GMBH
48 EFIAE0111060 CUBE4D 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) Multi Instrument support3) FootSwitch 4) PC mouse 5) Service Keyboard 6)DVI monitor cable 7) VGA monitor cable 8) Monitor cable control 9) HDMI monitor cable 10) SDI video Cable 11) Power Cable (US) Fiagon Navigation Unit FIAGON GMBH
49 EFIAE0111031 1 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) Fiagon Navigation Unit FIAGON GMBH
50 EFIAE0110091 1 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. Navigation Headrest Trumpf FIAGON GMBH