No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 20805832010012 | 41773 | 41773 | Disposable Reflective Marker Spheres (DRMS) attached to reference frames and sur Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 Spheres per tray, 30 trays, 90 spheres total. | OLO,HAW | Orthopedic Stereotaxic Instrument,Neurological Stereotaxic Instrument | Disposable Reflective Marker Sphere (DRMS) | |
2 | 00805832040039 | 8800739 | 8800739 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per inner pouch with 4 inner pouches in an outer pouch. There are 5 pouch-in-pouches for a total of 20 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
3 | 00805832040022 | 8800738 | 8800738 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per pouch with 3 pouches in another pouch. There are 5 pouch-in-pouches for a total of 15 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
4 | 00805832040015 | 8800737 | 8800737 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per pouch with 1 pouch in another pouch. There are 5 pouch-in-pouches for a total of 5 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
5 | 00805832030047 | 8801320 | 8801320 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 10 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 20 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
6 | 00805832030030 | 8800966 | 8800966 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 15 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 30 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
7 | 00805832030023 | 8800967 | 8800967 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 12 spheres per tray in a pouch. There are 2 tray-in-pouches for a total of 24 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
8 | 00805832030016 | 8800965 | 8800965 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 9 sphere per tray in a pouch. There are 2 tray-in-pouches for a total of 18 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
9 | 00805832020048 | 8801002 | 8801002 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Spheres |
10 | 00805832020031 | 8801054 | 8801054 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres. | HAW | Neurological Stereotaxic Instrument | NDI Passive Spheres | |
11 | 00805832020024 | 8801053 | 8801053 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 36 spheres. | HAW | Neurological Stereotaxic Instrument | NDI Passive Spheres | |
12 | 00805832020017 | 8801051 | 8801051 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 12 spheres. | HAW | Neurological Stereotaxic Instrument | NDI Passive Spheres | |
13 | 00805832070043 | 8801085 | 8801085 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There is 1 tray-in-pouch for a total of 5 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Sphere |
14 | 00805832070036 | 8801075 | 8801075 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Sphere |
15 | 00805832070029 | 8801074 | 8801074 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Sphere |
16 | 00805832070012 | 8801071 | 8801071 | Disposable Reflective Spheres attached to reference frames and surgical instrume Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery.One retail carton is made up of 1 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 12 spheres. | HAW | Neurological Stereotaxic Instrument | 2 | NDI Passive Sphere |
17 | 20805832010029 | 41774 | 41774 | Disposable Reflective Marker Spheres (DRMS) attached to reference frames and sur Disposable Reflective Marker Spheres (DRMS) attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 3 spheres per tray, 90 trays, 270 spheres total. | HAW,OLO | Neurological Stereotaxic Instrument,Orthopedic Stereotaxic Instrument | 2 | Disposable Reflective Marker Spheres (DRMS) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00880304716452 | 86-S313131 | 86-S313131 | SELEX INSERTER HANDLE | BIOMET ORTHOPEDICS, LLC | |
2 | 00880304643826 | 86-555523 | 86-555523 | MIH CURVED ACETABULAR IMPACTER HANDLE | BIOMET ORTHOPEDICS, LLC | |
3 | 00880304461413 | 86-555500 | 86-555500 | STRAIGHT EXACT BROACH HANDLE | BIOMET ORTHOPEDICS, LLC | |
4 | 00873263008669 | 66-IT(AR29)-00866 | 66-IT(AR29) | microTargeting Insertion Tube with Stylet, nonsterile | microTargeting™ Insertion Tube with Stylet | FHC, INC. |
5 | 00873263008614 | 66-MO-08-00861 | 66-MO-08 | Multi-Oblique Platform 2.5mm Tool Guide (60mm), 1X | microTargeting™ Multi-Oblique Tool Guide | FHC, INC. |
6 | 00873263008591 | 66-EL-EA-01-00859 | 66-EL-EA-01 | Single Electrode Adapter for IT(ME1), 1x | microTargeting™ Single Electrode Carrier Set | FHC, INC. |
7 | 00873263008584 | 66-IT-ME1P-00858 | 66-IT-ME1P | microTargeting Insertion Tube with Stylet, 258.9mm | microTargeting™ Insertion Tube | FHC, INC. |
8 | 00873263008546 | 70-FA-LX-NN-00854 | 70-FA-LX-NN | STar™ Frame Adapter, 1x for Leksell Stereotactic System® 1.6 mm | STar™ Drive Frame Adapter | FHC, INC. |
9 | 00873263008508 | 66-AC-LD-00850 | 66-AC-LD | Lower Lead Depth Stop, 1x with hex wrench | Lower Lead Depth Stop | FHC, INC. |
10 | 00873263008492 | 70-IT-1023-00849 | 70-IT-1023 | 33 cm Lead Insertion Tube Set, for use with microTargeting STar Drive | 33 cm Lead Insertion Tube Set | FHC, INC. |
11 | 00873263008485 | 66-IT-4010S-00848 | 66-IT-4010S | microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH microTargeting Nexframe Insertion Tube Set with Stylet, Sterile. Contains: IT(KH3): Insertion Tube - 205.6mm tube length, 1.83mm od, 1.6mm id PT(KH1): Protective Tube - 0.58mm id. Nexframe Stylet. | microTargeting™ NexFrame® Insertion Tube Kit | FHC, INC. |
12 | 00873263008478 | C0284-00847 | C0284 | Entry Offset Positioner (2mm I.D.) | microTargeting™ Platform | FHC, INC. |
13 | 00873263008461 | C0283-00846 | C0283 | Center Positioner (2mm I.D.) | microTargeting™ Platform | FHC, INC. |
14 | 00873263008454 | 66-IT-VP-03-00845 | 66-IT-VP-03 | 2.0 mm O.D. Verification Probe, 1xfor use with microTargeting™ STar™ Drive and m 2.0 mm O.D. Verification Probe, 1xfor use with microTargeting™ STar™ Drive and microTargeting™ Platform | microTargeting™ Verification Probe | FHC, INC. |
15 | 00873263008447 | MP-KIT-A-PS-00844 | MP-KIT-A-PS | Six-Trajectory Bilateral Platform Phantom | microTargeting™ Platform Accessory | FHC, INC. |
16 | 00873263008430 | MP-KIT-P-SG-00843 | MP-KIT-P-SG | Six-Trajectory Bilateral Platform | microTargeting™ Platform | FHC, INC. |
17 | 00873263008423 | 66-IT-SG1P-00842 | 66-IT-SG1P | 2.0mm O.D Insertion Tube with Stylet 127.1 mm | microTargeting™ Insertion Tube with Stylet | FHC, INC. |
18 | 00873263008393 | 66-DA-FT-03-00839 | 66-DA-FT-03 | WayPoint Fiducial Placement Template, 10x, nonsterile | WayPoint™ Fiducial Placement Template | FHC, INC. |
19 | 00873263008386 | 66-WP-IN-00838 | 66-WP-IN | inomed Adapter for microTargeting™ Platform | inomed Adapter | FHC, INC. |
20 | 00873263008362 | FC8014-00836 | FC8014 | Lower Lead Depth Stop, 1x with hex wrench | Lower Lead Depth Stop | FHC, INC. |
21 | 00873263008355 | FC8013-00835 | FC8013 | Electrode Depth Stop Adapter, 1.8mm for use with mT or STar Drive Systems | microTargeting™ Depth Stop | FHC, INC. |
22 | 00873263008331 | FC8008-00833 | FC8008 | STar™ Drive Locking Array Electrode Carrier | STar™ Drive Electrode Carrier | FHC, INC. |
23 | 00873263008324 | FC8006-00832 | FC8006 | STar™ Drive Frame Adapter for use with Leibinger ZD stereotactic frame | STar™ Drive Frame Adapter | FHC, INC. |
24 | 00873263008317 | FC8005-00831 | FC8005 | STar™ Drive Frame Adapter for use with Leibinger RM stereotactic frame | STar™ Drive Frame Adapter | FHC, INC. |
25 | 00873263008300 | FC8004-00830 | FC8004 | STar™ Drive Frame Adapter for use with Radionics CRW stereotactic frame | STar™ Drive Frame Adapter | FHC, INC. |
26 | 00873263008294 | FC8003-00829 | FC8003 | STar™ Drive Frame Adapter for use with Leskell stereotactic frame | STar™ Drive Frame Adapter | FHC, INC. |
27 | 00873263008287 | FC8002-00828 | FC8002 | STar™ Drive M/E, Motor/Encoder version | STar™ Drive M/E | FHC, INC. |
28 | 00873263008270 | FC8001-00827 | FC8001 | STar™ Drive MA, manually operated | STar™ Drive MA | FHC, INC. |
29 | 00873263008263 | FC1008-00826 | FC1008 | microTargeting Controller with motor option for use with STar and mT Drives | microTargeting™ Controller with Motor | FHC, INC. |
30 | 00873263008256 | 66-ST-12-00825 | 66-ST-12 | microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive | microTargeting™ Stylet | FHC, INC. |
31 | 00873263008249 | 66-ST-12P-00824 | 66-ST-12P | microTargeting DP Stylet, for use with mT Drive and STar Drive | microTargeting™ Stylet | FHC, INC. |
32 | 00873263008218 | 66-IT-15P-00821 | 66-IT-15P | microTargeting™ Insertion Tube with Stylet, sterile | microTargeting™ Insertion Tube with Stylet | FHC, INC. |
33 | 00873263008195 | FC8014-00819 | FC8014 | Lower Lead Depth Stop, 1x with hex wrench | Lower Lead Depth Stop | FHC, INC. |
34 | 00873263008171 | 66-IT(AR31)-00817 | 66-IT(AR31) | microTargeting Insertion Tube with Stylet, nonsterile, 1x | microTargeting™ Insertion Tube with Stylet | FHC, INC. |
35 | 00873263008140 | 66-WP-NV(4.6)-00814 | 66-WP-NV(4.6) | WayPoint Navigator Workstation Version 4.6, 1x | WayPoint™ Navigator | FHC, INC. |
36 | 00873263008126 | MP-KIT-P-NB-00812 | MP-KIT-P-NB | microTargeting™ Ablation Platform, 1x | microTargeting™ Platform | FHC, INC. |
37 | 00873263008102 | 66-MO-07-00810 | 66-MO-07 | Multi-Oblique Platform 3.2mm Tool Guide (60mm), 1X | microTargeting™ Multi-Oblique Tool Guide | FHC, INC. |
38 | 00873263008089 | C0258-00808 | C0258 | Guideline 4000™ Resident Expert Software Module, 1x | Resident Expert Software Module | FHC, INC. |
39 | 00873263008027 | C0305-00802 | C0305 | STar Adapter for ROSA Surgical Robot | Microtargeting ™ STar Drive Adapter | FHC, INC. |
40 | 00873263008010 | 66-IT-11P-00801 | 66-IT-11P | microTargeting™ Single Electrode Insertion Tube Set with Bullet TipStylet at tar microTargeting™ Single Electrode Insertion Tube Set with Bullet TipStylet at target, 1x, Sterile. Contains:IT(BP11) Insertion Tube – 219mm tube length, 1.83mm od, 1.6mm idPT(JN11) Protective Tube - 1.27mm od, .84mm id | microTargeting™ Insertion Tube Set | FHC, INC. |
41 | 00873263007877 | C0244-00787 | C0244 | Waypoint™ Navigator -Academic License | Waypoint™ Navigator | FHC, INC. |
42 | 00873263007860 | C0243-00786 | C0243 | Waypoint™ Navigator -Pay-per-use License | Waypoint™ Navigator | FHC, INC. |
43 | 00873263007853 | C0242-00785 | C0242 | Waypoint™ Navigator - Enterprise License | Waypoint™ Navigator | FHC, INC. |
44 | 00873263007846 | C0241-00784 | C0241 | WayPoint Navigator - Standard License | WayPoint™ Navigator | FHC, INC. |
45 | 00873263007839 | C0240-00783 | C0240 | WayPoint Navigator - Laptop | WayPoint™ Navigator | FHC, INC. |
46 | 00873263007822 | C0239-00782 | C0239 | WayPoint ™ Navigator - Starter License | WayPoint™ Navigator | FHC, INC. |
47 | 00873263007808 | DB-2040-00780 | DB-2040 | Bilateral Nexframe System for Medtronic StealthStation Navigation Systems | Nexframe | FHC, INC. |
48 | 00873263007723 | MI-2000-00772 | MI-2000 | MI-2000 NEXDRIVE™ Micropositioning Drive | NEXDRIVE™ | FHC, INC. |
49 | 00873263007716 | MI-1000-00771 | MI-1000 | MI-1000 NEXDRIVE™ Micropositioning Drive with Display Option | NEXDRIVE™ w/DIG | FHC, INC. |
50 | 00873263007709 | NP-1000-00770 | NP-1000 | NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic Syste NP-1000 Nexprobe Image-guided Probe for use with the Nexframe Stereotactic System and Medtronic StealthStation Navigation Systems | Nexprobe® | FHC, INC. |