Other products from "SCOPIS GMBH"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Field generator mounting arm
2 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Field generator planar
3 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Suction tube Frazier EM
4 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Instrument clamp 6-10 mm
5 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 NOVA AR
6 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 NOVA AR
7 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 NOVA AR
8 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Instrument clamp forceps
9 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. PGW Ear, Nose, And Throat Stereotaxic Instrument Patient tracker tabs (PU 100)
10 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Patient tracker EM mini
11 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Hybrid Navigation Unit EM
12 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Instrument clip 4 mm
13 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Instrument port
14 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Universal Tracker EM
15 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Suction tube Eicken EM
16 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 NOVA Basic
17 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Calibration body EM
18 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Endoscope tracker EM
19 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Patient tracker EM-D mini
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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Instrument clamp 10-16 mm
21 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Registration pointer EM-D
22 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. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 Instrument clamp 2-6 mm
Other products with the same Product Code "PGW"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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
2 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
3 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
4 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
5 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
6 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
7 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
8 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
9 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
10 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
11 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
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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
23 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
24 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
25 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
26 EFIAE0114301 v2 E 01 1430 Accessory to Cube navigation systems. Device for registration. VirtuEye FIAGON GMBH
27 EFIAE0114201 1 E 01 1420 Accessory to Fiagon navigation systems. Device for registration. VirtuEye V1 FIAGON GMBH
28 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
29 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
30 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
31 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 Navigation Headrest Office FIAGON GMBH
32 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 Navigation Headrest Universal FIAGON GMBH
33 EFIAE0110021 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. Navigation Headrest Maquet FIAGON GMBH
34 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. Navigation Headrest Flat FIAGON GMBH
35 EFIAE0030011 1 E 00 3001 Adhesive Pad FIAGON GMBH
36 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. MapperFrame FIAGON GMBH
37 00850002250275 8000-010-011 The TGS Universal Headrest Adapter is a component of the TGS Universal Headrest The TGS Universal Headrest Adapter is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. TGS Universal Headrest Adapter C ENTELLUS MEDICAL, INC.
38 00850002250268 8000-010-010 The TGS Universal Headrest Adapter is a component of the TGS Universal Headrest The TGS Universal Headrest Adapter is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. TGS Universal Headrest Adapter B ENTELLUS MEDICAL, INC.
39 00850002250251 8000-010-009 The TGS Universal Headrest Adapter is a component of the TGS Universal Headrest The TGS Universal Headrest Adapter is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. TGS Universal Headrest Adapter A ENTELLUS MEDICAL, INC.
40 00850002250244 8000-010-008 The TGS Universal Mounting Arm is a component of the TGS Universal Headrest with The TGS Universal Mounting Arm is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. TGS Universal Headrest Mounting Arm ENTELLUS MEDICAL, INC.
41 00850002250237 8000-010-007 The TGS Universal Headrest is a component of the TGS Universal Headrest with Mou The TGS Universal Headrest is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. It also provides a resting surfaced for the patient to place their head during procedures requiring navigation. TGS Universal Headrest ENTELLUS MEDICAL, INC.
42 00850002250220 TGSGW 8000-060-009 The TGS Guidewire is intended as an aid for precisely locating anatomical struct The TGS Guidewire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The TGS Guidewire is intended to be used with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System. TGS Guidewire ENTELLUS MEDICAL, INC.
43 00763000588434 9735019 SUCTION 9735019 MALLEABLE STD TIP 12-FR AxiEM™ MEDTRONIC NAVIGATION, INC.
44 00763000588427 9735018 SUCTION 9735018 MALLEABLE BALL TIP 9-FR AxiEM™ MEDTRONIC NAVIGATION, INC.
45 00763000588410 9735017 SUCTION 9735017 MALLEABLE ANGLE TIP 9-FR AxiEM™ MEDTRONIC NAVIGATION, INC.
46 00763000588403 9735016 SUCTION 9735016 MALLEABLE STD TIP 9-FR AxiEM™ MEDTRONIC NAVIGATION, INC.
47 00763000588397 9735015 SUCTION 9735015 MALLEABLE STD TIP 7-FR AxiEM™ MEDTRONIC NAVIGATION, INC.
48 00763000532123 9735762 SW 9735762 APP STLTH S8 V2.0 APP SteathStation MEDTRONIC NAVIGATION, INC.
49 00763000532109 9736226 SW KIT 9736226 2.0 STLTH FLEX ENT SteathStation MEDTRONIC NAVIGATION, INC.
50 00763000531836 9735920 SW KIT 9735920 S8 2.0 ENT PLAN STATION SteathStation MEDTRONIC NAVIGATION, INC.