No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840682142052 | EKB2 | MUE | Full field digital, system, x-ray, mammographic | 2 | Senographe Pristina | ||
2 | 00840682118460 | EKB1 | MUE,IWX,ITY,FMQ,IZO,IXJ,IZW | Full field digital,system,x-ray,mammographic,Barrier, control panel, x-ray, mova Full field digital,system,x-ray,mammographic,Barrier, control panel, x-ray, movable,Assembly, tube housing, x-ray, diagnostic,Restraint, protective,Generator, high-voltage, x-ray, diagnostic,Grid, radiographic,Collimator, automatic, radiographic | 1 | Senographe Pristina | ||
3 | 00840682145879 | EKB3 | MUE | Full field digital, system, x-ray, mammographic | 2 | Senographe Pristina | ||
4 | 00840682141307 | IGS WF SP | OWB,OXO,IZI,JAA | Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray sy Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, angiographic,System, x-ray, fluoroscopic, image-intensified | 2 | NA | ||
5 | 00840682117852 | Accelera V5 | MUE | Full field digital,system,x-ray,mammographic | 2 | NA | ||
6 | 00840682102278 | 4.7 | LLZ | System, image processing, radiological | 2 | AW | ||
7 | 00195278276971 | EKB6 | Senographe Pristina Core System | MUE | Full field digital, system, x-ray, mammographic | 2 | Senographe Pristina | |
8 | 00195278223937 | EKB5 | Senographe Pristina Core System | MUE | Full field digital, system, x-ray, mammographic | 2 | Senographe Pristina | |
9 | 00195278022745 | EKB4 | Senographe Pristina Core System | MUE | Full field digital, system, x-ray, mammographic | 2 | Senographe Pristina | |
10 | 00840682142038 | M3-2 SP1 STD+ | OTE | Digital breast tomosynthesis | 3 | not applicable | ||
11 | 00840682146845 | PRISTINA 2.0 | Software Pristina Infinity | OTE,MUE | Digital breast tomosynthesis,Full field digital, system, x-ray, mammographic | 2 | not applicable | |
12 | 00840682145862 | PRISTINA 0.0A | MUE | Full field digital, system, x-ray, mammographic | 2 | not applicable | ||
13 | 00840682143516 | PRISTINA 0.0 | MUE | Full field digital, system, x-ray, mammographic | 2 | not applicable | ||
14 | 00840682142373 | PRISTINA 0.1 | MUE | Full field digital, system, x-ray, mammographic | 2 | not applicable | ||
15 | 00840682141284 | NA | IZI,OWB,JAA,OXO | System, x-ray, angiographic,Interventional fluoroscopic x-ray system,System, x-r System, x-ray, angiographic,Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | IGS WF BP | ||
16 | 00840682139229 | KAS1 | MUE | Full field digital, system, x-ray, mammographic | 2 | Pristina Serena | ||
17 | 00840682125802 | M3-2 | MUE | Full field digital,system,x-ray,mammographic | 2 | not applicable | ||
18 | 00840682122603 | 5727669 | IZO,FMQ,IWX,IXJ,ITY,MUE,IZW | Generator, high-voltage, x-ray, diagnostic,Restraint, protective,Barrier, contro Generator, high-voltage, x-ray, diagnostic,Restraint, protective,Barrier, control panel, x-ray, movable,Grid, radiographic,Assembly, tube housing, x-ray, diagnostic,Full field digital,system,x-ray,mammographic,Collimator, automatic, radiographic | 1 | not applicable | ||
19 | 00195278347596 | KAS2 | Biopsy Option | MUE | Full field digital, system, x-ray, mammographic | 2 | Pristina Serena | |
20 | 00195278009289 | PRISTINA 0.0B | OTE,MUE | Digital breast tomosynthesis,Full field digital, system, x-ray, mammographic | 2 | not applicable | ||
21 | 00840682124638 | IGS 7 001 | OXO,OWB,JAA,IZI | Image-Intensified Fluoroscopic X-Ray System, Mobile,Interventional Fluoroscopic Image-Intensified Fluoroscopic X-Ray System, Mobile,Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified,System, X-Ray, Angiographic | 2 | DISCOVERY | ||
22 | 00840682120142 | ATA1 | OTE | Digital breast tomosynthesis | 3 | Senographe Pristina 3D | ||
23 | 00840682110693 | IGS 740 002 | DISCOVERY IGS 740 002 | JAA,OWB,OXO | System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray system, mobile | 2 | DISCOVERY | |
24 | 00840682110648 | IGS 730 002 | DISCOVERY IGS 730 002 | OWB,JAA,IZI | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic | 2 | DISCOVERY | |
25 | 00840682104739 | IGS 730 001 | OWB,JAA,IZI | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic | 2 | DISCOVERY | ||
26 | 00195278194039 | ATA2 | Kit upgrade HW Single PC Infinity | OTE | Digital breast tomosynthesis | 3 | Senographe Pristina 3D | |
27 | 00840682143424 | BSP1 | MUE | Full field digital, system, x-ray, mammographic | 2 | Breast Spacer | ||
28 | 00840682139397 | JMM1 | MUE | Full field digital, system, x-ray, mammographic | 2 | Horizontal | ||
29 | 00840682121064 | GPE1 | MUE | Full field digital,system,x-ray,mammographic | 2 | SenoBright | ||
30 | 00195278485168 | IGS 3 | 5874604 | Allia IGS3 UDI | JAA,OWB,IZI | System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray system,System, x-ray, angiographic | 2 | Allia |
31 | 00195278485144 | IGS 5 | 5872892 | Allia IGS5 UDI | OWB,JAA,IZI | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic | 2 | Allia |
32 | 00195278215550 | IGS 7 OR 001 | 5855630 | Allia IGS 7 OR UDI | OWB,JAA,IZI,OXO | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic,Image-intensified fluoroscopic x-ray system, mobile | 2 | Allia |
33 | 00195278215543 | IGS 7 001 | 5855628 | Allia IGS 7 UDI | JAA,IZI,OXO,OWB | System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic,Image System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic,Image-intensified fluoroscopic x-ray system, mobile,Interventional fluoroscopic x-ray system | 2 | Allia |
34 | 00840682138826 | MAG5 | FMQ | Restraint, protective | 1 | MagStand 1.5 | ||
35 | 00840682125888 | IGS 7 OR 001 | OXO,OWB,JAA,IZI | Image-Intensified Fluoroscopic X-Ray System, Mobile,Interventional Fluoroscopic Image-Intensified Fluoroscopic X-Ray System, Mobile,Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified,System, X-Ray, Angiographic | 2 | Discovery | ||
36 | 00840682123297 | EST6 | IZH | System, x-ray, mammographic | 2 | Senographe Essential Stereotaxy | ||
37 | 00840682147767 | 1 | LLZ | System, image processing, radiological | 2 | SenoIris | ||
38 | 00840682143486 | SIM1 | MUE | Full field digital, system, x-ray, mammographic | 2 | Sample Imaging | ||
39 | 00840682102384 | 3.2 | LLZ | System, image processing, radiological | 2 | AW Server | ||
40 | 00840682100076 | LLH2 | 5434135-5 | Digital Breast Tomosynthesis option for Senographe Essential | OTE | Digital Breast Tomosynthesis | 3 | SenoClaire |
41 | 00840682100045 | LLH1 | 5434135-4 | Digital Breast Tomosynthesis option for Senographe Essential | OTE | Digital Breast Tomosynthesis | 3 | SenoClaire |
42 | 00840682147378 | IGS 3 001 | OWB,JAA,IZI | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,System, x-ray, angiographic | 2 | INNOVA | ||
43 | 00840682141581 | RT 001 | JAK,JAA | System, x-ray, tomography, computed,System, x-ray, fluoroscopic, image-intensified | 2 | INTERACT Discovery | ||
44 | 00840682138802 | MAG8 | FMQ | Restraint, protective | 1 | MagStand 1.8 | ||
45 | 00840682124621 | IGS 5 001 | Innova IGS 5 UDI | JAA,OWB,IZI | System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray System, x-ray, fluoroscopic, image-intensified,Interventional fluoroscopic x-ray system,System, x-ray, angiographic | 2 | INNOVA | |
46 | 00840682124614 | IGS 6 001 | OWB,JAA,IZI | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Inte Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified,System, X-Ray, Angiographic | 2 | INNOVA | ||
47 | 00840682123242 | ES14 | MUE | Full field digital,system,x-ray,mammographic | 2 | Senographe Essential | ||
48 | 00840682121637 | UPG X100 001 | IZI,OWB,JAA | System, x-ray, angiographic,Interventional fluoroscopic x-ray system,System, x-r System, x-ray, angiographic,Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified | 2 | INNOVA | ||
49 | 00840682110709 | IGS 540 002 | INNOVA IGS 540 002 | OWB,IZI,JAA | Interventional fluoroscopic x-ray system,System, x-ray, angiographic,System, x-r Interventional fluoroscopic x-ray system,System, x-ray, angiographic,System, x-ray, fluoroscopic, image-intensified | 2 | INNOVA | |
50 | 00840682110129 | IGS 520 002 | INNOVA IGS 520 002 | OWB,IZI,JAA | Interventional fluoroscopic x-ray system,System, x-ray, angiographic,System, x-r Interventional fluoroscopic x-ray system,System, x-ray, angiographic,System, x-ray, fluoroscopic, image-intensified | 2 | INNOVA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00613994416209 | BI40000015 | SPACER BI40000015 O-ARM PATIENT SPACER | O-ARM® | MEDTRONIC NAVIGATION, INC. | |
2 | 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. |
3 | 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. |
4 | 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. |
5 | 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. |
6 | 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. |
7 | 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. |
8 | 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. |
9 | 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. |
10 | 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. |
11 | 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. |
12 | 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. |
13 | 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. |
14 | 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. |
15 | 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. |
16 | 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. |
17 | 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. |
18 | 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. |
19 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
20 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
21 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
22 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
23 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
24 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
25 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
26 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
27 | 00195377081667 | LNPULSELRGE9 | Pulse Loaner LessRay GE 9in Set | PULSE | NUVASIVE, INC. | |
28 | 00195377081667 | LNPULSELRGE9 | Pulse Loaner LessRay GE 9in Set | PULSE | NUVASIVE, INC. | |
29 | 00195377081636 | LNPULSELRBED | Pulse Loaner LessRay Bed Array Set | PULSE | NUVASIVE, INC. | |
30 | 00195377081636 | LNPULSELRBED | Pulse Loaner LessRay Bed Array Set | PULSE | NUVASIVE, INC. | |
31 | 00195377081629 | LNPULSEIOM | Pulse Loaner IOM Set | PULSE | NUVASIVE, INC. | |
32 | 00195377081629 | LNPULSEIOM | Pulse Loaner IOM Set | PULSE | NUVASIVE, INC. | |
33 | 00195377081605 | LNPULSEDRILLGUIDE | Pulse Loaner Drill Guide | PULSE | NUVASIVE, INC. | |
34 | 00195377081605 | LNPULSEDRILLGUIDE | Pulse Loaner Drill Guide | PULSE | NUVASIVE, INC. | |
35 | 00195377081490 | LNPULSECAMCART | Pulse Loaner Camera Cart Set | PULSE | NUVASIVE, INC. | |
36 | 00195377081490 | LNPULSECAMCART | Pulse Loaner Camera Cart Set | PULSE | NUVASIVE, INC. | |
37 | 00195377081483 | LNPULSECAM | Pulse Loaner Camera Set | PULSE | NUVASIVE, INC. | |
38 | 00195377081483 | LNPULSECAM | Pulse Loaner Camera Set | PULSE | NUVASIVE, INC. | |
39 | 00195377065544 | 1802497 | PULSE Software, v4.0.0-bln.eu | PULSE | NUVASIVE, INC. | |
40 | 00195377065544 | 1802497 | PULSE Software, v4.0.0-bln.eu | PULSE | NUVASIVE, INC. | |
41 | 00195377065537 | 1802495 | PULSE Software, v4.0.0-bln.us | PULSE | NUVASIVE, INC. | |
42 | 00195377065537 | 1802495 | PULSE Software, v4.0.0-bln.us | PULSE | NUVASIVE, INC. | |
43 | 00195377065520 | 1802493 | PULSE Software, v4.0.0-bl.eu | PULSE | NUVASIVE, INC. | |
44 | 00195377065520 | 1802493 | PULSE Software, v4.0.0-bl.eu | PULSE | NUVASIVE, INC. | |
45 | 00195377065513 | 1802491 | PULSE Software, v4.0.0-bl.us | PULSE | NUVASIVE, INC. | |
46 | 00195377065513 | 1802491 | PULSE Software, v4.0.0-bl.us | PULSE | NUVASIVE, INC. | |
47 | 00195377065506 | 1802489 | PULSE Software, Base Image | PULSE | NUVASIVE, INC. | |
48 | 00195377065506 | 1802489 | PULSE Software, Base Image | PULSE | NUVASIVE, INC. | |
49 | 00195377062406 | PULSELRTABLET | Pulse LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
50 | 00195377062406 | PULSELRTABLET | Pulse LessRay Tablet Set | PULSE | NUVASIVE, INC. |