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 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
11 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
12 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
13 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
14 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. PGW Ear, Nose, And Throat Stereotaxic Instrument PointerTube Keat
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 B057U9020010 1.0 U9 020 01 Patient tracker tabs are circular, medical grade, double-sided adhesive tape. Th Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references products Patient tracker EM mini or Patient tracker EM-D mini to the patient during surgery. Patient tracker tabs (PU 100) SCOPIS GMBH
2 B057U40140 2.6.8 U4 014 The Navigation Software NOVA Basic provides import of image sets, building the i The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy. NOVA Basic SCOPIS GMBH
3 B057U4003260170 2.6.17 U4 003 The Navigation Software NOVA AR provides import of image sets, building the imag The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy. NOVA AR SCOPIS GMBH
4 B057U4003260160 2.6.16 U4 003 The Navigation Software NOCA AR provides import of image sets, building the imag The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy. NOVA AR SCOPIS GMBH
5 B057U40030 2.6.15 U4 003 The Navigation Software NOVA AR provides import of image sets, building the imag The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy. NOVA AR SCOPIS GMBH
6 B057U3011010 1.0 U3 011 01 The Field generator mounting arm serves as a mounting for the Field generator. T The Field generator mounting arm serves as a mounting for the Field generator. The screw at its central hinge locks the position of all three joints. The base of the arm is clamped to the standard rail mount of surgical operation tables. Field generator mounting arm SCOPIS GMBH
7 B057U3010010 1.0 U3 010 01 The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to cr The Scopis Hybrid Navigation System EM utilizes the Field Generator planar to create the electromagnetic field for navigation of surgical instruments.The EM Field Generator planar is connected to a mounting arm for placement close to the surgical area. Field generator planar SCOPIS GMBH
8 B057U2040040 2.2 U2 040 04 The Hybrid Navigation Unit EM is a high performance computer workstation with bu The Hybrid Navigation Unit EM is a high performance computer workstation with built-in electromagnetic Localization System. The workstation runs the navigation software NOVA which imports radiologic image via DICOM. Hybrid Navigation Unit EM SCOPIS GMBH
9 B057U1085400 1.0 U1 085 40 The Instrument clip EM 4 mm provides a way to track the location of compatible c The Instrument clip EM 4 mm provides a way to track the location of compatible conventional surgical instruments. After performing a calibration step the tip of the conventional instrument can be navigated. The clip connects to the Hybrid Navigation Unit EM via an integrated cable.The clip is provided non-sterile and is intended to be sterilized by the user.The Instrument clip EM 4 mm is reusable. Instrument clip 4 mm SCOPIS GMBH
10 B057U1049010 1.0 U1 049 01 The Instrument port is a sterile handling port for the other EM navigated instru The Instrument port is a sterile handling port for the other EM navigated instruments. The Instrument port connects to the Hybrid Navigation Unit EM on one side and to an EM navigated instrument on the other.The Instrument port is provided non-sterile and is intended to be sterilized by the user.The Instrument port is reusable. Instrument port SCOPIS GMBH
11 B057U1046020 1.0 U1 046 02 The Universal tracker EM provides a way to track the location of compatible conv The Universal tracker EM provides a way to track the location of compatible conventional surgical instruments. It is mounted on the conventional instrument with a suitable instrument clamp and calibrated to navigate the tip of instrument. The Universal tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable.The Universal tracker EM is provided non-sterile and is intended to be sterilized by the user.The Universal tracker EM is reusable. Universal Tracker EM SCOPIS GMBH
12 B057U1038020 1.0 U1 038 02 The Calibration body EM is used to calibrate a surgical endoscope which is track The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable.The Calibration body EM is provided non-sterile and is intended to be sterilized by the user.The Calibration body EM is reusable. Calibration body EM SCOPIS GMBH
13 B057U1037020 1.0 U1 037 02 The Endoscope tracker EM provides a way to track the location of compatible conv The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable.The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user.The Endoscope tracker EM is reusable. Endoscope tracker EM SCOPIS GMBH
14 B057U1031300 1.0 U1 031 30 The Patient Tracker EM-D mini provides a reference point on the patient. This re The Patient Tracker EM-D mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable.The Patient Tracker EM-D mini is provided non-sterile and is intended for high-level disinfection only.The Patient Tracker EM-D mini is reusable. Patient tracker EM-D mini SCOPIS GMBH
15 B057U1031120 1.0 U1 031 12 The Patient Tracker EM mini provides a reference point on the patient. This refe The Patient Tracker EM mini provides a reference point on the patient. This reference defines the patient location and is used to correlate the patient anatomy to the image set. The Patient Tracker connects to the Navigation Unit via an integrated cable.The Patient Tracker EM mini is provided non-sterile and is intended to be sterilized by the user.The Patient Tracker EM mini is reusable. Patient tracker EM mini SCOPIS GMBH
16 B057U1030120 1.0 U1 030 12 The Suction tube Eicken EM provides an electromagnetically tracked instrument th The Suction tube Eicken EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables.Suction tubes are provided non-sterile and are intended to be sterilized by the user.Suction tubes are reusable. Suction tube Eicken EM SCOPIS GMBH
17 B057U1030110 1.0 U1 030 11 The Suction tube Frazier EM provides an electromagnetically tracked instrument t The Suction tube Frazier EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables.Suction tubes are provided non-sterile and is intended to be sterilized by the user.Suction tubes are reusable. Suction tube Frazier EM SCOPIS GMBH
18 B057U1029030 1.0 U1 029 03 The Registration Pointer EM-D is an electromagnetically tracked instrument with The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register the patient anatomy. The location of the instrument is referenced relative to a patient tracker affixed to the patient’s anatomy. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.The Precision Pointer EM-D is provided non-sterile and is intended intended for high-level disinfection only. It is intended to be used prior to surgical draping while the patient environment is not covered under sterile drape. The Registration Pointer EM-D is reusable. Registration pointer EM-D SCOPIS GMBH
19 B057U1029010 1.0 U1 029 01 The Precision Pointer EM is an electromagnetically tracked instrument that is us The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomical space. The location of the instrument is referenced relative to a patient tracker that is attached to the patient. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.The Precision Pointer EM is provided non-sterile and is intended to be sterilized by the user. The Precision Pointer EM is reusable. Precision Pointer EM SCOPIS GMBH
20 B057U1017050 1.0 U1 017 05 The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of i The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable. Instrument clamp 10-16 mm SCOPIS GMBH
21 B057U1017030 1.0 U1 017 03 The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of in The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable. Instrument clamp 6-10 mm SCOPIS GMBH
22 B057U1017020 1.0 U1 017 02 The Instrument clamp forceps is part of a clamp set that provides mounting of in The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable. Instrument clamp forceps SCOPIS GMBH
23 B057U1017010 1.0 U1 017 01 The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of ins The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To track the location of compatible surgical instruments an instrument clamp with appropriate diameter is fixed to a rigid portion of the instrument and equipped with a Universal tracker EM.Instrument clamps are provided non-sterile and are intended to be sterilized by the user.Instrument clamps are reusable. Instrument clamp 2-6 mm SCOPIS GMBH
24 37613327413275 8000-100-001 8000-100-001 Patient Tracker Tabs n/a STRYKER LEIBINGER GMBH & CO. KG
25 20705031469300 TSB460Z TSB460Z Trudi Shaver Blade 4.0mm - 60° Curved - 1pk TruDi Shaver Blade ACCLARENT, INC.
26 20705031469287 TSB415Z TSB415Z Trudi Shaver Blade 4.0mm - 15° Curved - 1pk TruDi Shaver Blade ACCLARENT, INC.
27 20705031469263 TSB440Z TSB440Z Trudi Shaver Blade 4.0mm - 40° Curved - 1pk TruDi Shaver Blade ACCLARENT, INC.
28 20705031469256 TSB3STRZ TSB3STRZ Trudi Shaver Blade 3.0mm - Straight (0°)- 1pk TruDi Shaver Blade ACCLARENT, INC.
29 20705031469225 TSB4STRZ TSB4STRZ Trudi Shaver Blade 4.0mm - Straight (0°)- 1pk TruDi Shaver Blade ACCLARENT, INC.
30 20705031465616 PVT0616Z PVT0616Z ACCLARENT PIVOT Balloon Dilation System - 1PK ACCLARENT PIVOT ACCLARENT, INC.
31 20705031465609 PVT0616NZ PVT0616NZ ACCLARENT PIVOT Navigation Balloon Dilation System - 1PK ACCLARENT PIVOT ACCLARENT, INC.
32 20705031465586 PVT0616LZ PVT0616LZ ACCLARENT PIVOT Illumination Balloon Dilation System - 1PK ACCLARENT PIVOT ACCLARENT, INC.
33 20705031465432 TDC0005Z TDC0005Z TruDi Curette, 0°, 5IN - 1PK TruDi Curette ACCLARENT, INC.
34 20705031464220 TDP0705Z TDP0705Z TruDi Probe, 70°, 5in - 1PK TruDi Probe ACCLARENT, INC.
35 20705031464213 TDP0005Z TDP0005Z TruDi Probe, 0°, 5in - 1PK TruDi Probe ACCLARENT, INC.
36 20705031245911 TDNW001Z TDNW001Z TruDi NAVWIRE Sinus Navigation Guidewire - 1PK TruDi NAVWIRE ACCLARENT, INC.
37 20705031245867 TDNC001Z TDNC001Z TruDi NAV Cable - 1PK TruDi NAV Cable ACCLARENT, INC.
38 20705031245430 RSP0616MFSNZ RSP0616MFSNZ RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK RELIEVA SPINPLUS NAV ACCLARENT, INC.
39 20705031245423 RSP0516MFSNZ RSP0516MFSNZ RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT - 1PK RELIEVA SPINPLUS NAV ACCLARENT, INC.
40 20705031242903 GW35150NZ1PK GW35150NZ1PK ACCLARENT NAVWIRE SINUS NAVIGATION GUIDEWIRE ACCLARENT NAVWIRE ACCLARENT, INC.
41 10846835018639 1 FG-2000-00 TruDi™ Navigation System TruDi™ Navigation System BIOSENSE WEBSTER (ISRAEL) LTD.
42 10846835017182 1 FG-2000-00 ACCLARENT® ENT Navigation System Carto ENT BIOSENSE WEBSTER (ISRAEL) LTD.
43 10705031469297 TSB415 TSB415 Trudi Shaver Blade 4.0mm - 15° Curved - 5pk TruDi Shaver Blade ACCLARENT, INC.
44 10705031469273 TSB440 TSB440 Trudi Shaver Blade 4.0mm - 40° Curved - 5pk TruDi Shaver Blade ACCLARENT, INC.
45 10705031469242 TSB3STR TSB3STR Trudi Shaver Blade 3.0mm - Straight (0°)- 5pk TruDi Shaver Blade ACCLARENT, INC.
46 10705031469235 TSB4STR TSB4STR Trudi Shaver Blade 4.0mm - Straight (0°)- 5pk TruDi Shaver Blade ACCLARENT, INC.
47 10705031469211 TSB460 TSB460 Trudi Shaver Blade 4.0mm - 60° Curved - 5pk TruDi Shaver Blade ACCLARENT, INC.
48 10705031465596 PVT0616N PVT0616N ACCLARENT PIVOT Navigation Balloon Dilation System ACCLARENT PIVOT ACCLARENT, INC.
49 10705031465572 PVT0616L PVT0616L ACCLARENT PIVOT Illumination Balloon Dilation System ACCLARENT PIVOT ACCLARENT, INC.
50 10705031465565 PVT0616 PVT0616 ACCLARENT PIVOT Balloon Dilation System ACCLARENT PIVOT ACCLARENT, INC.