No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884838108899 | 300007314091 | HD 8Ch WRIST ARRAY (Receive Only) | MOS | Coil, Magnetic Resonance, Specialty | 2 | GE HEALTHCARE | |
2 | 00884838055322 | 781341 | Magnetic Resonance Equipment | LNI,LNH | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | Ingenia 1.5T | |
3 | 00884838106970 | 6 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
4 | 00884838104570 | ClarifEye - 1 | 002120 | Software medical device. Intended for use by professional healthcare providers a Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy. | OWB,LLZ,JAK,OLO | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological, Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological,System, X-Ray, Tomography, Computed,Orthopedic Stereotaxic Instrument | 2 | ClarifEye |
5 | 00884838101890 | StentBoost Live - 2 | 001017 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. | OWB,LLZ | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological | 2 | StentBoost Live |
6 | 00884838100107 | 5 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
7 | 00884838099272 | Azurion 7 B20 | 722226 | Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch fl Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector), ceiling-mounted lateral stand (12-inch or 15-inch flat detector) and optional interface for an OR table. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Azurion |
8 | 00884838095250 | 4.2 | 830089 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
9 | 00884838085268 | Azurion 7 M20 | 722079 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inch flat detector. Optionally the ceiling-mounted configuration has an interface for an OR table | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Azurion |
10 | 00884838085220 | 2.2 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular | |
11 | 00884838093072 | 4.1 | 98960612681X | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
12 | 00884838091429 | 3.2 | 98960612660X | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
13 | 00884838090668 | Onvision system | 453561943492 | Intended to be used during peripheral nerve block procedures. Tracks the positio Intended to be used during peripheral nerve block procedures. Tracks the position of the B.Braun Onvision needle tip position on the ultrasound image by overlaying a circle at the given location. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Onvision system |
14 | 00884838087460 | 3.1 | 98960612483X | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
15 | 00884838085251 | Azurion 7 M12 | 722078 | Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane syst Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 12-inch flat detector. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Azurion |
16 | 00884838085770 | 2.3 | 98960612341x | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular |
17 | 00884838084544 | Philips Hemodynamic Application - 1 | 002010 | Software medical device. Intended for use by professional healthcare providers f Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. | MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Philips Hemodynamic Application |
18 | 00884838080812 | StentBoost Live - 1 | 001017 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides real-time enhanced visualization of stents in coronary vessels. Supports the user in placing and deploying stents. | OWB,LLZ | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological | 2 | StentBoost Live |
19 | 00884838076730 | 1.2 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular | |
20 | 00884838075214 | 2.1 | Cardiovascular Image and Information Management Solution (CVIS) | LLZ | System, image processing, radiological | 2 | IntelliSpace Cardiovascular | |
21 | 00884838059269 | StentBoost - 4 | 001007 | Software medical device, used with a Philips Interventional X-Ray System. Provid Software medical device, used with a Philips Interventional X-Ray System. Provides high resolution visualization of stents in vessels. Supports the user in placing and deploying stents. | OWB,LLZ | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological | 2 | StentBoost |
22 | 00884838059238 | MR-CT Roadmap - 1 | 001004 | Software medical device, used with a Philips Interventional X-Ray System. Extens Software medical device, used with a Philips Interventional X-Ray System. Extension of 3D-RA. Provides live 3D image guidance for navigating endovascular devices through vascular structures. | OWB,LLZ,JAK | Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological, Interventional Fluoroscopic X-Ray System,System, Image Processing, Radiological,System, X-Ray, Tomography, Computed | 2 | MR-CT Roadmap |
23 | 00884838059191 | Interventional Workspot - 1 | 001000 | Software medical device hosting platform, used with a Philips Interventional X-R Software medical device hosting platform, used with a Philips Interventional X-Ray System. Provides common functionalities (e.g. import / export, data handling) for other software medical devices. | LLZ,OWB | System, Image Processing, Radiological,Interventional Fluoroscopic X-Ray System | 2 | Interventional Workspot |
24 | 00884838083325 | 728231 | JAK | System, x-ray, tomography, computed | 2 | Brilliance CT | ||
25 | 00884838114388 | 300009321831 | Medial Array Coil VT | MOS | Coil, Magnetic Resonance, Specialty | 2 | DUNLEE SENITNELLE | |
26 | 00884838108646 | Ingenia 1.5T | 782140 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
27 | 00884838108639 | Ingenia Ambition S | 782139 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
28 | 00884838108622 | Ingenia Ambition X | 782138 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
29 | 00884838108615 | Ingenia Elition S | 782137 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
30 | 00884838108608 | Ingenia Elition X | 782136 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
31 | 00884838104129 | Ingenia Elition X | 782119 | The Ingenia Elition X with the gradient and RF designs, as well as Compressed SE The Ingenia Elition X with the gradient and RF designs, as well as Compressed SENSE delivers on superb image quality, improves patient handling setup time and combines this with accelerations in both 2D- and 3D scanning. | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
32 | 00884838099715 | Ingenia 1.5T | 781315 | LNH,LNI | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic | 2 | Ingenia | |
33 | 00884838099500 | HA FlexTrak II | 989710008732 | The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and The HA FlexTrak II is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
34 | 00884838099494 | Tabletop extender | 989603008792 | A moveable tabletop which combined with the standard table top enables a maximum A moveable tabletop which combined with the standard table top enables a maximum field of view of 200cm. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
35 | 00884838099487 | Trolley | 989603008226 | The Patient Trolley Frame is a stainless steel frame with four wheels for easy t The Patient Trolley Frame is a stainless steel frame with four wheels for easy transportation of the patient positioned on the system's tabletop. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
36 | 00884838099470 | HA FlexTrak | 989710006412 | The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and all The HA FlexTrak is Height-adjustable to facilitate easy patient transfer and allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
37 | 00884838099463 | FlexTrak | 989710006402 | The FlexTrak allows patient preparation for an examination while the previous pa The FlexTrak allows patient preparation for an examination while the previous patient is being scanned. Positioning of coils, positioning aids, monitoring and triggering equipment can be done outside the examination room. | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
38 | 00884838099456 | Acoustic Hood | 989603022784 | "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
39 | 00884838099449 | Acoustic Hood | 989603020982 | "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head "The Achieva acoustic hood is designed to be used with the SENSE Pediatric Head Spine coil and the SENSE Pediatric Body/Cardiac coil and their mattresses.The acoustic will provide good acoustic noise damping for vulnerable neonatal patients requiring MR examinations.Premature patients are scanned while their acoustic sensory system is still in development and should be protected. Very small children will not always tolerate a headset." | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Ingenia |
40 | 00884838098343 | Ingenia Ambition S | 782108 | Ingenia Ambition S | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
41 | 00884838098336 | Ingenia Elition X | 782107 | Ingenia Elition X | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
42 | 00884838098329 | Ingenia Elition S | 782106 | Ingenia Elition S | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
43 | 00884838099340 | AltaTrack equipment | 4322 070 2535 X | The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FO The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. | DQK | Computer, Diagnostic, Programmable | 2 | AltaTrack |
44 | 00884838099043 | Ingenia 1.5T | 782115 | Enables trained physicians to obtain cross-sectional and spectroscopic images of Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
45 | 00884838098350 | Ingenia Ambition X | 782109 | Ingenia Ambition X | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
46 | 00884838095083 | Smartpath to dStream for 3.0T | 781270 | LNH,LNI | System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance sp System, nuclear magnetic resonance imaging,System, nuclear magnetic resonance spectroscopic | 2 | Ingenia | |
47 | 00884838098312 | Ingenia 3.0T CX | 782105 | We’ve designed Ingenia 3.0T CX with the performance that helps you explore with We’ve designed Ingenia 3.0T CX with the performance that helps you explore with confidence, perform advanced clinical imaging that supports referrals, and conduct routine imaging efficiently. Thanks in part to exceptional Qua | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
48 | 00884838098299 | Ingenia 3.0T | 782103 | Ingenia 3.0T | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
49 | 00884838098275 | Ingenia 1.5T | 782101 | Ingenia 1.5T | LNH | System, nuclear magnetic resonance imaging | 2 | Ingenia |
50 | 00884838095076 | Smartpath to dStream for 1.5T | 781260 | MRDD Equipment | LNI,LNH | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | Ingenia |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00195451000416 | 12.0x30mm | L6IVL120030 | The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. | Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter | SHOCKWAVE MEDICAL, INC. |
2 | 00195451000409 | 10.0x30mm | L6IVL100030 | The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. | Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter | SHOCKWAVE MEDICAL, INC. |
3 | 00195451000393 | 9.0x30mm | L6IVL090030 | The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. | Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter | SHOCKWAVE MEDICAL, INC. |
4 | 00195451000386 | 8.0x30mm | L6IVL080030 | The IVL Catheter is a proprietary lithotripsy device delivered through the perip The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm.The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable. | Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter | SHOCKWAVE MEDICAL, INC. |
5 | 00195451000348 | 4.0x40mm | S4IVLK4040 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave S4 | SHOCKWAVE MEDICAL, INC. |
6 | 00195451000331 | 3.5x40mm | S4IVLK3540 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave S4 | SHOCKWAVE MEDICAL, INC. |
7 | 00195451000324 | 3.0x40mm | S4IVLK3040 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave S4 | SHOCKWAVE MEDICAL, INC. |
8 | 00195451000317 | 2.5x40mm | S4IVLK2540 | The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array o The Shockwave S4 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The distal catheter and balloon are hydrophilic coated to increase lubricity. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave S4 | SHOCKWAVE MEDICAL, INC. |
9 | 00195451000287 | 8.0x60mm | M5PIVL8060 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
10 | 00195451000270 | 7.0x60mm | M5PIVL7060 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
11 | 00195451000263 | 6.5x60mm | M5PIVL6560 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
12 | 00195451000256 | 6.0x60mm | M5PIVL6060 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
13 | 00195451000249 | 5.5x60mm | M5PIVL5560 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
14 | 00195451000232 | 5.0x60mm | M5PIVL5060 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
15 | 00195451000225 | 4.5x60mm | M5PIVL4560 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
16 | 00195451000218 | 4.0x60mm | M5PIVL4060 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
17 | 00195451000201 | 3.5x60mm | M5PIVL3560 | The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator). | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ | SHOCKWAVE MEDICAL, INC. |
18 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
19 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
20 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
21 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
22 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
23 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
24 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
25 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
26 | 00195377081667 | LNPULSELRGE9 | Pulse Loaner LessRay GE 9in Set | PULSE | NUVASIVE, INC. | |
27 | 00195377081667 | LNPULSELRGE9 | Pulse Loaner LessRay GE 9in Set | PULSE | NUVASIVE, INC. | |
28 | 00195377081636 | LNPULSELRBED | Pulse Loaner LessRay Bed Array Set | PULSE | NUVASIVE, INC. | |
29 | 00195377081636 | LNPULSELRBED | Pulse Loaner LessRay Bed Array Set | PULSE | NUVASIVE, INC. | |
30 | 00195377081629 | LNPULSEIOM | Pulse Loaner IOM Set | PULSE | NUVASIVE, INC. | |
31 | 00195377081629 | LNPULSEIOM | Pulse Loaner IOM Set | PULSE | NUVASIVE, INC. | |
32 | 00195377081605 | LNPULSEDRILLGUIDE | Pulse Loaner Drill Guide | PULSE | NUVASIVE, INC. | |
33 | 00195377081605 | LNPULSEDRILLGUIDE | Pulse Loaner Drill Guide | PULSE | NUVASIVE, INC. | |
34 | 00195377081490 | LNPULSECAMCART | Pulse Loaner Camera Cart Set | PULSE | NUVASIVE, INC. | |
35 | 00195377081490 | LNPULSECAMCART | Pulse Loaner Camera Cart Set | PULSE | NUVASIVE, INC. | |
36 | 00195377081483 | LNPULSECAM | Pulse Loaner Camera Set | PULSE | NUVASIVE, INC. | |
37 | 00195377081483 | LNPULSECAM | Pulse Loaner Camera Set | PULSE | NUVASIVE, INC. | |
38 | 00195377065544 | 1802497 | PULSE Software, v4.0.0-bln.eu | PULSE | NUVASIVE, INC. | |
39 | 00195377065544 | 1802497 | PULSE Software, v4.0.0-bln.eu | PULSE | NUVASIVE, INC. | |
40 | 00195377065537 | 1802495 | PULSE Software, v4.0.0-bln.us | PULSE | NUVASIVE, INC. | |
41 | 00195377065537 | 1802495 | PULSE Software, v4.0.0-bln.us | PULSE | NUVASIVE, INC. | |
42 | 00195377065520 | 1802493 | PULSE Software, v4.0.0-bl.eu | PULSE | NUVASIVE, INC. | |
43 | 00195377065520 | 1802493 | PULSE Software, v4.0.0-bl.eu | PULSE | NUVASIVE, INC. | |
44 | 00195377065513 | 1802491 | PULSE Software, v4.0.0-bl.us | PULSE | NUVASIVE, INC. | |
45 | 00195377065513 | 1802491 | PULSE Software, v4.0.0-bl.us | PULSE | NUVASIVE, INC. | |
46 | 00195377065506 | 1802489 | PULSE Software, Base Image | PULSE | NUVASIVE, INC. | |
47 | 00195377065506 | 1802489 | PULSE Software, Base Image | PULSE | NUVASIVE, INC. | |
48 | 00195377062406 | PULSELRTABLET | Pulse LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
49 | 00195377062406 | PULSELRTABLET | Pulse LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
50 | 00195377062239 | PULSEIOM | Pulse IOM Set | PULSE | NUVASIVE, INC. |