No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | H787MRC3S970 | MRC3S97 | C3 WAVE REMOTE BATTERY ACC | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
2 | H787MRC3S950 | MRC3S95 | C3 WAVE IPAD CASE ACCESSORY | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
3 | H787MRC3S940 | MRC3S94 | C3 WAVE QUICK RELEASE CLAMP | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
4 | H787MRC3S900 | MRC3S90 | C3 WAVE HUB ACCESSORY | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | C3 WAVE SYSTEM | |
5 | H787203001010 | 20300101 | NanoKnife Generator | OAB | Low energy direct current thermal ablation system | 2 | NanoKnife | |
6 | H787117197110 | 11719711 | Mariner Hydrophilic Coated Angiographic Catheter, Cobra (2), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | Mariner | ||
7 | H965814001240 | 81400124 | Y-ADAPTOR,LG.BORE,FINE THREAD W/10" FLEXCIL EXT.-OEM | DTL | Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass | 2 | NAMIC | |
8 | H965800450750 | 80045075 | NEEDLE GUIDEWIRE INTRODUCER - OEM | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NAMIC | |
9 | H965252000 | 25-200 | AngioVac F18 85 Cannula | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | 2 | AngioVac | |
10 | H965251940 | 25194 | AngioVac C180 with Obturator | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | AngioVac | ||
11 | H965251930 | 25193 | AngioVac C20 with Obturator | DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass | AngioVac | ||
12 | H787128002040 | 12800204 | SpeedLyser Infusion Catheter Basic Kit | QEY | Mechanical thrombolysis catheter | SpeedLyser | ||
13 | H787506002190 | 50600219 | AngiOptic Angiographic Catheter, Cobra (1), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
14 | H787506001480 | 50600148 | AngiOptic Angiographic Catheter, Sos Omni Selective (0), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
15 | H787506001310 | 50600131 | AngiOptic Angiographic Catheter, Sos Omni Selective (2), Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
16 | H787506001210 | 50600121 | AngiOptic Angiographic Catheter, Straight Art, Non-Braided | DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | AngiOptic | ||
17 | H787128002020 | 12800202 | SpeedLyser Infusion Catheter Basic Kit | QEY | Mechanical thrombolysis catheter | SpeedLyser | ||
18 | H787128002010 | 12800201 | SpeedLyser Infusion Catheter Basic Kit | QEY | Mechanical thrombolysis catheter | SpeedLyser | ||
19 | H787124018640 | 12401864 | Uni-Fuse+ Infusion System 5F, 135cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
20 | H787124018630 | 12401863 | Uni-Fuse+ Infusion System 5F, 135cm, 2cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
21 | H787124018620 | 12401862 | Uni-Fuse+ Infusion System 5F, 90cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
22 | H787124018610 | 12401861 | Uni-Fuse+ Infusion System 5F, 90cm, 2cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
23 | H787124018600 | 12401860 | Uni-Fuse+ Infusion System 4.3F, 135cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
24 | H787124018590 | 12401859 | Uni-Fuse+ Infusion System 4.3F, 135cm, 2cm | KRA | Catheter, continuous flush | Uni-Fuse+ | ||
25 | H787124018580 | 12401858 | Uni-Fuse+ Infusion System 4.3F, 90cm, 15cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
26 | H787124018570 | 12401857 | Uni-Fuse+ Infusion System 4.3F, 90cm, 2cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
27 | H787124018550 | 12401855 | Uni-Fuse+ Infusion System 4.3F, 135cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
28 | H787124018540 | 12401854 | Uni-Fuse+ Infusion System 4.3F, 135cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
29 | H787124018520 | 12401852 | Uni-Fuse+ Infusion System 4.3F, 90cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
30 | H787124018510 | 12401851 | Uni-Fuse+ Infusion System 4.3F, 90cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
31 | H787124018490 | 12401849 | Uni-Fuse+ Infusion System 5F, 135cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
32 | H787124018480 | 12401848 | Uni-Fuse+ Infusion System 5F, 135cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
33 | H787124018460 | 12401846 | Uni-Fuse+ Infusion System 5F, 90cm, 10cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
34 | H787124018450 | 12401845 | Uni-Fuse+ Infusion System 5F, 90cm, 5cm | KRA | Catheter, continuous flush | 2 | Uni-Fuse+ | |
35 | H787124018440 | 12401844 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
36 | H787124018430 | 12401843 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
37 | H787124018420 | 12401842 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
38 | H787124018410 | 12401841 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
39 | H787124018380 | 12401838 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
40 | H787124018370 | 12401837 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
41 | H787124018360 | 12401836 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
42 | H787124018350 | 12401835 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
43 | H787124018340 | 12401834 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
44 | H787124018330 | 12401833 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
45 | H787124018320 | 12401832 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
46 | H787124018310 | 12401831 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
47 | H787124018300 | 12401830 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
48 | H787124018290 | 12401829 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
49 | H787124018280 | 12401828 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse | ||
50 | H787124018270 | 12401827 | UniFuse Infusion System w/ Cooper Wire | KRA | Catheter, continuous flush | UniFuse |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10607567106793 | 0684-00-0254-17 | 0684-00-0254-17 | Guide Wire 3mm J Tip 0.035" x 55cm Stainless Steel Uncoated Introducer Wire | Guide Wire 3mm J Tip 0.035" x 55cm Stainless Steel Uncoated Introducer Wire | DATASCOPE CORP. |
2 | 10607567106663 | 0684-00-0254-16 | 0684-00-0254-16 | Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silico Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silicone overcoat | Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silico | DATASCOPE CORP. |
3 | 10607567106618 | 0684-00-0254-15 | 0684-00-0254-15 | Guide Wire 3mm J Tip 0.025" x 260 cm PTFE Coated (Type L) Fixed core | Guide Wire 3mm J Tip 0.025" x 260 cm PTFE Coated (Type L) Fixed core | DATASCOPE CORP. |
4 | 10607567106601 | 0684-00-0254-14 | 0684-00-0254-14 | Guide Wire 3mm J Tip 0.025" x 175 cm PTFE Coated (Type L) Fixed core | Guide Wire 3mm J Tip 0.025" x 175 cm PTFE Coated (Type L) Fixed core | DATASCOPE CORP. |
5 | 10607567105925 | 0684-00-0254-09 | 0684-00-0254-09 | Guide Wire 3mm J Tip 0.025" x 145 cm PTFE Coated (Type L) Fixed core | Guide Wire 3mm J Tip 0.025" x 145 cm PTFE Coated (Type L) Fixed core | DATASCOPE CORP. |
6 | M58800101005611 | 1 | 001-010056-1 | "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " | Vdrive Drape | STEREOTAXIS, INC. |
7 | M58800100411590 | II | 001-004115-9 | The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | Cardiodrive System | STEREOTAXIS, INC. |
8 | M588001004115120 | II | 001-004115-12 | The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | Cardiodrive System | STEREOTAXIS, INC. |
9 | M588001004115110 | II | 001-004115-11 | The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | Cardiodrive System | STEREOTAXIS, INC. |
10 | M58800100246910 | 1 | 001-002469-1 | Vdrive with V-Sono is indicated for remotely controlling the advancement, retrac Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium | V-Sono Intracardiac Echo Manipulator | STEREOTAXIS, INC. |
11 | M58800100245210 | 1 | 001-002452-1 | The Vdrive with V-Loop disposable is indicated to remotely control the advanceme The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures | V-Loop Variable Loop Catheter Manipulator | STEREOTAXIS, INC. |
12 | M58800100242210 | 1 | 001-002422-1 | The Vdrive with V-CAS Disposable is indicated for remotely controlling the advan The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System | V-CAS Catheter Advancement System | STEREOTAXIS, INC. |
13 | M58800100230720 | Duo | 001-002307-2 | "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " | Vdrive System | STEREOTAXIS, INC. |
14 | M58800100230710 | Single Arm | 001-002307-1 | "The Vdrive® system is intended to stabilize, navigate and remotely control: • C "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). " | Vdrive System | STEREOTAXIS, INC. |
15 | M5880010017712 | 1 | 001-001771-2 | The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | Cardiodrive Hemostasis Adapter - SJ | STEREOTAXIS, INC. |
16 | M5880010017711 | 1 | 001-001771-1 | The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | QuikCAS Hemostasis Adapter | STEREOTAXIS, INC. |
17 | M58800100175110 | 1 | 001-001751-1 | The Stereotaxis Cardiodrive is intended for automatically advancing and retracti The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. | QuikCAS Cardiodrive Sterile Components | STEREOTAXIS, INC. |
18 | M58800100111411 | IV-1 | 0010011141 | Hemostasis Adapter IV Spares, Box, Device Count(5) | Hemostasis Adapter | STEREOTAXIS, INC. |
19 | 10195327188955 | DYNJGWIRE20L | DYNJGWIRE20L | GUIDEWIRE 3MMJ 0.035X260CM LT | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
20 | 10195327157937 | SAMPC0683 | SAMPC0683 | TEST KIT FOR DYNJGWIRE01 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
21 | 10195327024116 | DNSC127758 | DNSC127758 | GUIDEWIRE .038X260 3MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
22 | 10195327024086 | DNSC127753 | DNSC127753 | GUIDEWIRE .038X260 STR TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
23 | 10195327023959 | DNSC17297 | DNSC17297 | GUIDEWIRE .038X150 3MMJ TCMC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
24 | 10195327023874 | DNSC88924 | DNSC88924 | GUIDEWIRE.038X150 BENTSON FCHB | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
25 | 10195327023867 | DNSC127757 | DNSC127757 | GUIDEWIRE .038X150 STR TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
26 | 10195327023850 | DNSC127755 | DNSC127755 | GUIDEWIRE .038X150 3MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
27 | 10195327023843 | DNSC127754 | DNSC127754 | GUIDEWIRE .038X150 3MMJ MOVE | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
28 | 10195327017385 | DNSC127746 | DNSC127746 | GUIDEWIRE .035X175 ROSN 1.5MMJ | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
29 | 10195327017378 | DNSC133170 | DNSC133170 | GUIDEWIRE .035X260 ROSEN 1.5MJ | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
30 | 10195327017361 | DNSC125612 | DNSC125612 | GUIDEWIRE .035X260CM BENTSON | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
31 | 10195327017354 | DNSC127752 | DNSC127752 | GUIDEWIRE .035X260 STR TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
32 | 10195327017347 | DNSC135892 | DNSC135892 | GUIDEWIRE .035IN 210CM 1.5MMJ | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
33 | 10195327017330 | DNSC88923 | DNSC88923 | GUIDEWIRE.035X180 DE 3MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
34 | 10195327017279 | DNSC22609 | DNSC22609 | GUIDEWIRE.035X150 3MMJ TCMC HB | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
35 | 10195327017231 | DNSC49744 | DNSC49744 | GUIDEWIRE.035X150 3MMJ TCFCLLT | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
36 | 10195327017224 | DNSC127750 | DNSC127750 | GUIDEWIRE .035X150 1.5MMJ STR | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
37 | 10195327017217 | DNSC127749 | DNSC127749 | GUIDEWIRE .035X150 STR FC HEP | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
38 | 10195327017125 | DNSC127748 | DNSC127748 | GUIDEWIRE .035X150 15MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
39 | 10195327016845 | DNSC127760 | DNSC127760 | GUIDEWIRE .032X150 3MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
40 | 10195327016838 | DNSC127946 | DNSC127946 | GUIDEWIRE .032X60 STRGHT TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
41 | 10195327016234 | DNSC127759 | DNSC127759 | GUIDEWIRE .025X150 3MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
42 | 10195327015473 | DNSC127751 | DNSC127751 | GUIDEWIRE .025X150 STR TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
43 | 10195327013783 | DNSC94209 | DNSC94209 | GUIDEWIRE .018X260 3MMJ TCFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
44 | 10195327013745 | DNSC125826 | DNSC125826 | GUIDEWIRE .018X145CM TGSTN STR | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
45 | 10195327013738 | DNSC132766 | DNSC132766 | GUIDEWIRE .035X180 HEP 10IN | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
46 | 10195327013721 | DNSC131200 | DNSC131200 | GUIDEWIRE .035X180 1.5MMJ FC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
47 | 10195327013639 | DNSC125448 | DNSC125448 | GUIDEWIRE .035X150CM STRAIGHT | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
48 | 10195327013622 | DNSC119362 | DNSC119362 | GUIDEWIRE 0.35X210CM 1.5MM J | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
49 | 10195327013301 | DNSC138064 | DNSC138064 | GUIDEWIRE .038X150CM 3MMJ FC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |
50 | 10195327012984 | DNSC31038 | DNSC31038 | GUIDEWIRE .035X70 DE 3MMJ SFC | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. |