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 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
16 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
17 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
18 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
19 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
20 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
21 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
22 EFIAE0114201 1 E 01 1420 Accessory to Fiagon navigation systems. Device for registration. PGW Ear, Nose, And Throat Stereotaxic Instrument 2 VirtuEye V1
23 EFIAE0135921 1 E 01 3592 Inflation device for Vensure Balloon Dilation System LRC Instrument, Ent Manual Surgical 1 Vensure Inflation Device
24 EFIAE0135161 1 LRC Instrument, Ent Manual Surgical 1 VenSure Nav Balloon Sinus Dilation System
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 EFIAE0135061 1 E 01 3506 LRC Instrument, Ent Manual Surgical 1 VenSure Balloon Sinus Dilation System
45 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
46 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
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 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.