No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00887517399779 | 6942044 | CoRoent® XLR, 20x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
2 | 00887517399700 | 6941844 | CoRoent® XLR, 18x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
3 | 00887517399335 | 6941644 | CoRoent® XLR, 16x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
4 | 00887517398765 | 6941444 | CoRoent® XLR, 14x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
5 | 00887517398499 | 6941244 | CoRoent® XLR, 12x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
6 | 00887517398420 | 6941044 | CoRoent® XLR, 10x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
7 | 00887517398055 | 6932088 | CoRoent® XLR, 20x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
8 | 00887517397683 | 6931888 | CoRoent® XLR, 18x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
9 | 00887517397256 | 6931688 | CoRoent® XLR, 16x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
10 | 00887517396822 | 6931488 | CoRoent® XLR, 14x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
11 | 00887517396457 | 6931288 | CoRoent® XLR, 12x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
12 | 00887517395641 | 6922088 | CoRoent® XLR, 20x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
13 | 00887517395634 | 6922044 | CoRoent® XLR, 20x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
14 | 00887517395269 | 6921888 | CoRoent® XLR, 18x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
15 | 00887517395252 | 6921844 | CoRoent® XLR, 18x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
16 | 00887517394880 | 6921688 | CoRoent® XLR, 16x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
17 | 00887517394873 | 6921660 | CoRoent® XL Wide, 16x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
18 | 00887517394866 | 6921655 | CoRoent® XL Wide, 16x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
19 | 00887517394859 | 6921650 | CoRoent® XL Wide, 16x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
20 | 00887517394842 | 6921645 | CoRoent® XL Wide, 16x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
21 | 00887517394835 | 6921644 | CoRoent® XLR, 16x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
22 | 00887517394569 | 6921488 | CoRoent® XLR, 14x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
23 | 00887517394552 | 6921460 | CoRoent® XL Wide, 14x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
24 | 00887517394545 | 6921455 | CoRoent® XL Wide, 14x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
25 | 00887517394538 | 6921450 | CoRoent® XL Wide, 14x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
26 | 00887517394521 | 6921445 | CoRoent® XL Wide, 14x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
27 | 00887517394514 | 6921444 | CoRoent® XLR, 14x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
28 | 00887517394149 | 6921288 | CoRoent® XLR, 12x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
29 | 00887517394132 | 6921260 | CoRoent® XL Wide, 12x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
30 | 00887517394125 | 6921255 | CoRoent® XL Wide, 12x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
31 | 00887517394118 | 6921250 | CoRoent® XL Wide, 12x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
32 | 00887517394101 | 6921245 | CoRoent® XL Wide, 12x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
33 | 00887517393791 | 6921244 | CoRoent® XLR, 12x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
34 | 00887517393722 | 6921088 | CoRoent® XLR, 10x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
35 | 00887517393715 | 6921060 | CoRoent® XL Wide, 10x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
36 | 00887517393708 | 6921055 | CoRoent® XL Wide, 10x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
37 | 00887517393395 | 6921050 | CoRoent® XL Wide, 10x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
38 | 00887517393388 | 6921045 | CoRoent® XL Wide, 10x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
39 | 00887517393371 | 6921044 | CoRoent® XLR, 10x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
40 | 00887517393333 | 6920860 | CoRoent® XL Wide, 8x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
41 | 00887517393326 | 6920855 | CoRoent® XL Wide, 8x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
42 | 00887517393319 | 6920850 | CoRoent® XL Wide, 8x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
43 | 00887517393302 | 6920845 | CoRoent® XL Wide, 8x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
44 | 00887517392961 | 6916860 | CoRoent® XL, 16x18x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
45 | 00887517392954 | 6916855 | CoRoent® XL, 16x18x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
46 | 00887517392947 | 6916850 | CoRoent® XL, 16x18x50mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
47 | 00887517392930 | 6916845 | CoRoent® XL, 16x18x45mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
48 | 00887517392923 | 6916840 | CoRoent® XL, 16x18x40mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
49 | 00887517392916 | 6916260 | CoRoent® XL Wide, 16x22x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
50 | 00887517392909 | 6916255 | CoRoent® XL Wide, 16x22x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent |
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 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
21 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
22 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
23 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
24 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
25 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
26 | 00195377108135 | 5050196 | PULSE Array, Cios Left | PULSE | NUVASIVE, INC. | |
27 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
28 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
29 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
30 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
31 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
32 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
33 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
34 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
35 | 00195377108128 | 5050195 | PULSE Array, Cios Right | PULSE | NUVASIVE, INC. | |
36 | 00195377092243 | 3999005 | RELINE C Driver, Reduction Screw | ReLine | NUVASIVE, INC. | |
37 | 00195377083234 | 10001123 | NAV.S Shankdriver, Cam Lock | ReLine | NUVASIVE, INC. | |
38 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
39 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
40 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
41 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
42 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
43 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
44 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
45 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
46 | 00195377081681 | LNPULSENAVINS | Pulse Loaner Nav Instrument Set | PULSE | NUVASIVE, INC. | |
47 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
48 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
49 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. | |
50 | 00195377081674 | LNPULSELRTABLET | Pulse Loaner LessRay Tablet Set | PULSE | NUVASIVE, INC. |