Other products from "ZIEN MEDICAL TECHNOLOGIES, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 B090C35175H0 C35-175-H C35-175-H The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 35
2 B090C35135H0 C35-135-H C35-135-H The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 35
3 B090C351350 C35-135 C35-135 The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 35
4 B090A70900 A7-090 A7-090 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. QEZ Aspiration Thrombectomy Catheter Control 7F Mechanical Thrombectomy System
5 B090A70600 A7-060 A7-060 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. QEZ Aspiration Thrombectomy Catheter Control 7F Mechanical Thrombectomy System
6 B090A50550 A5-055 A5-055 ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. DXE Catheter, Embolectomy 2 Aspire Max 5 Aspiration Catheter 55cm
7 B090A110900 A11-090 A11-090 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. QEZ Aspiration Thrombectomy Catheter Control 11F Mechanical Thrombectomy System
8 B0905XGW0 5X-GW 5X-GW Distal Access torque devices are used to maneuver guidewires in the coronary and Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature DQX Wire, Guide, Catheter SPINR
9 B090A110600 A11-060 A11-060 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. QEZ Aspiration Thrombectomy Catheter Control 11F Mechanical Thrombectomy System, 60cm
10 B09030ASP0 30-ASP 30-ASP ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a s ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a syringe is used. FMF Syringe, Piston Aspire Aspirator 30ml
11 B090A90900 A9-090 A9-090 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. QEZ Aspiration Thrombectomy Catheter Control 9F Mechanical Thrombectomy System, 90cm
12 B090A90600 A9-060 A9-060 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature. QEZ Aspiration Thrombectomy Catheter Control 9F Mechanical Thrombectomy System, 60cm
13 10853624005022 #15 Blade PB-M-15 The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend an The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position. GDX Scalpel, One-Piece PenBlade Safety Scalpel
14 10853624005015 #11P Blade PB-M-11P The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend an The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position. GDX Scalpel, One-Piece PenBlade Safety Scalpel
15 10853624005008 #10 Blade PB-M-10 The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend an The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position. GDX Scalpel, One-Piece PenBlade Safety Scalpel
16 B090PWR100 PWR-10 The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorpor The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures. FMF Syringe, Piston PowrSyringe
17 B090S6250650 S6.25-065 S6.25-065 The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature. PNO Catheter, Percutaneous, Cutting/Scoring XO Score
18 B090C14175H0 C14-175-H C14-175-H The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 14
19 B090C141750 C14-175 C14-175 The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 14
20 B090C14135H0 C14-135-H C14-135-H The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 14
21 B090C141350 C14-135 C14-135 The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 14
22 B090C14090H0 C14-090-H C14-090-H The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 14
23 B090C140900 C14-090 C14-090 The XO Cross device is a support catheter intended to guide and support a guidew The XO Cross device is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents. DQY Catheter, Percutaneous XO Cross 14
24 B090A61350 A6-135 A6-135 ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. DXE Catheter, Embolectomy 2 Aspire Max 6 Aspiration Catheter 135cm
25 B090A60550 A6-055 A6-055 ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. DXE Catheter, Embolectomy Aspire Max 6 Aspiration Catheter 55cm
26 B090A51350 A5-135 A5-135 ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. DXE Catheter, Embolectomy 2 Aspire Max 5 Aspiration Catheter 135cm
27 00860412001541 CATS-D CATS-D The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers The CATS-D Tonometer prism is intended to be used with Goldmann type tonometers for the measurements of intraocular pressure of the human eye. HKY Tonometer, Manual 2 CATS
28 00860412001510 CATS-R The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GA The CATS Tonometer Prism (CATS) is a modified Goldmann applanation tonometer (GAT) prism that is optimized to work with the GAT's operating system to reduce errors in the measurement due to patient anatomical variation. This is used to measure intraocular pressure by applying a known force on the globe of the eye and measuring intraocular tension by applanation. Tonometer prisms are assembled onto a GAT as a patient contacting component that is then utilized by the GAT to assess intraocular pressure. HKY Tonometer, Manual 2 CATS Tonometer
29 B090MT1010030 MT10-100-3 MT10-100-3 The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a c The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.” BYY Tube, Aspirating, Flexible, Connecting Control 10T Mechanical Thrombectomy System Tubing, 3-Pack
30 B090MT100 MT10 MT10 The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.” BYY Tube, Aspirating, Flexible, Connecting Control 10T Mechanical Thrombectomy Filter
31 B090MT10100F0 MT10-100-F MT10-100-F The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designe The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.” BYY Tube, Aspirating, Flexible, Connecting Control 10T Mechanical Thrombectomy System Tubing, Female Suction
32 B090MT101000 MT10-100 MT10-100 The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a c The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.” BYY Tube, Aspirating, Flexible, Connecting Control 10T Mechanical Thrombectomy System Tubing
33 B090ARXLP60 ARX-LP6 ARX-LP6 ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirato ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirator™ Drive Unit / Pump for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. DXE Catheter, Embolectomy 2 Aspire RX-LP6 Aspiration Catheter 136
34 00853989006170 XC-035-145B XC-035-145B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
35 00853989006163 XC-035-090B XC-035-090B XableCath is an over-th-wire catheter for facilitating guide wire and catheter a XableCath is an over-th-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
36 00853989006156 XC-018-145B XC-018-145B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
37 00853989006149 XC-018-090B XC-018-090B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
38 00853989006132 XC-014-145B XC-014-145B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
39 00853989006125 XC-014-090B XC-014-090B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
40 00853989006118 XC-035-065B XC-035-065B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
41 00853989006101 XC-018-065B XC-018-065B XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
42 00853989006095 XC-014-065B XC-014-065B XableCath is an over the wire catheter for facilitating guide wire and catheter XableCath is an over the wire catheter for facilitating guide wire and catheter access to peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
43 00853989006088 XC-035-145A XC-035-145A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
44 00853989006071 XC-035-090A XC-035-090A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
45 00853989006064 XC-035-065A XC-035-065A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
46 00853989006057 XC-018-145A XC-018-145A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
47 00853989006040 XC-018-090A XC-018-090A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
48 00853989006033 XC-018-065A XC-018-065A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
49 00853989006026 XC-014-145A XC-014-145A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
50 00853989006019 XC-014-090A XC-014-090A XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. DQY Catheter, Percutaneous 2 XableCath
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