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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 10194717105756 AN01041E OKE Port Introducer Kit 2 Regard™
2 10194717105749 HT01040D OEQ Angiography/Angioplasty Kit 2 Regard™
3 10194717105466 OR01009C OJH Orthopedic Tray 1 Regard™
4 10194717105077 GS00817F LRO General Surgery Tray 2 Regard™
5 10194717102236 GS00441P LRO General Surgery Tray 2 Regard™
6 10194717102205 GS00403H OHD Gynecological Laparoscopic Kit 2 Regard™
7 10194717100300 HT00271F OES Cardiac Catheterization Kit 2 Regard™
8 10194717104025 HT00235L OES Cardiac Catheterization Kit 2 Regard™
9 10194717106852 LD00044O MLS Labor And Delivery Kit 2 Regardo™
10 10194717116059 NU00260K Spine Pack OJH Orthopedic Tray 1 Regard
11 10194717115977 NU00303J Cervical OJG Neurological Tray 1 Regard
12 10194717115960 NU00260J Spine Pack OJH Orthopedic Tray 1 Regard
13 10194717115939 OR00258I Minor Ortho OJH Orthopedic Tray 1 Regard
14 10194717115427 NU00303I Cervical OJG Neurological Tray 1 Regard
15 10194717115403 NU00260I Spine Pack OJH Orthopedic Tray 1 Regard
16 10194717115380 NU00263Q Craniotomy OJG Neurological Tray 1 Regard
17 10194717114031 GS00823E STEREOTACTIC KIT LRO General Surgery Tray 2 Regard
18 10194717108931 OR01092A Hip Arthroscopy OJH Orthopedic Tray 1 Regard
19 10194717108924 AN01084D Anesthesia Bundle OGD Custom Anesthesia Tray 2 Regard
20 10194717108917 OR00769J CCOR Hand OJH Orthopedic Tray 1 Regard
21 10194717108900 GS00823D Stereotactic LRO General Surgery Tray 2 Regard
22 10194717108894 HT00468H Pacemaker OES Cardiac Catheterization Kit 2 Regard
23 10194717108887 UR00098S Cysto LRO General Surgery Tray 2 Regard
24 10194717108870 NU00263P Craniotomy OJG Neurological Tray 1 Regard
25 10194717108863 NU00303H Cervical OJG Neurological Tray 1 Regard
26 10194717108856 OR00258H Minor Ortho OJH Orthopedic Tray Regard
27 10194717108849 NU00260H Spine Pack OJH Orthopedic Tray 1 Regard
28 10194717108832 GS00401B Isolation Kit PXC Personal Protection Kit 1 Regard
29 10194717108825 NU00010X LAMINECTOMY OJG Neurological Tray 1 Regard
30 10194717108788 LD00427L C-Section OHM Cesarean Section Tray 2 Regard
31 10194717108771 OB00100Y C-Section OHM Cesarean Section Tray 2 Regard
32 10194717108764 OR00344J Knee Artho OJH Orthopedic Tray 1 Regard
33 10194717108757 OR00346K Total Knee OJH Orthopedic Tray 1 Regard
34 10194717108733 CV01003H CV 2 A&B OEZ Cardiovascular Procedure Kit 2 Regard
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37 10194717108689 Or00734K Total Knee OJH Orthopedic Tray 1 Regard
38 10194717108641 CV00364F Shuntagram OEQ Angiography/Angioplasty Kit 2 Regard
39 10194717100041 OR00240M OJH Orthopedic Tray 1 Regard™
40 10194717108412 OR00342L OJH Orthopedic Tray 1 Regard™
41 10194717106838 OR00107AE OJH Orthopedic Tray 1 Regard™
42 10194717105701 GS01036A LRO General Surgery Tray 2 Regard™
43 10194717105695 GU01035B FDE Laparoscopy Kit 2 Regard™
44 10194717105688 OR01034B OJH Orthopedic Tray 1 Regard™
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46 10194717105664 GS01032B LRO General Surgery Tray 2 Regard™
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7 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.
8 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.
9 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.
10 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.
11 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.
12 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.
13 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.
14 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.
15 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.
16 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.
17 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.
18 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.
19 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.
20 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.
21 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.
22 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.
23 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.
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