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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MEDITECH SPINE, LLC
S1-7-41141-16
In Commercial Distribution

  • B167S2741141161 ()
  • B167S4741141162 ()
  • B167S1741141160 ()


  • Spinal bone screw, non-bioabsorbable
Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9394
In Commercial Distribution

  • B13093941 ()
  • B13093942 ()
  • B13093943 ()


  • Nerve-locating system
Surgical Nerve Stimulator/Locator
Checkpoint Surgical, Inc.
9094
In Commercial Distribution

  • B13090941 ()
  • B13090942 ()
  • B13090943 ()


  • Nerve-locating system
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
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution

  • B090SPN10051 ()
  • B090SPN10050 ()
  • B090SPN10052 ()
SPN-1005

  • Torque manipulation device
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.50-065
In Commercial Distribution

  • B090S6500651 ()
  • B090S6500650 ()
  • B090S6500652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.50mm
S6.50-065

  • Peripheral angioplasty balloon catheter, basic
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
S6.25-065
In Commercial Distribution

  • B090S6250650 ()
  • B090S6250651 ()
  • B090S6250652 ()

  • Catheter Working Length: 65 Centimeter
  • Introducer Sheath Compatibility: 7 French
  • Catheter Gauge: 6.4 French
  • Scoring Depth, 0.25mm
S6.25-065

  • Peripheral angioplasty balloon catheter, basic
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
PWR-10
In Commercial Distribution

  • B090PWR101 ()
  • B090PWR100 ()
  • B090PWR102 ()


  • Angiographic syringe
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.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100-F
In Commercial Distribution

  • B090MT10100F1 ()
  • B090MT10100F0 ()
  • B090MT10100F2 ()
MT10-100-F

  • Thrombectomy tubing set, non-electronic
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.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100-3
In Commercial Distribution

  • B090MT1010031 ()
  • B090MT1010030 ()
  • B090MT1010032 ()
MT10-100-3

  • Thrombectomy tubing set, non-electronic
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.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10-100
In Commercial Distribution

  • B090MT101000 ()
  • B090MT101001 ()
  • B090MT101002 ()
MT10-100

  • Thrombectomy tubing set, non-electronic
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.”
ZIEN MEDICAL TECHNOLOGIES, INC.
MT10
In Commercial Distribution

  • B090MT101 ()
  • B090MT100 ()
  • B090MT102 ()
MT10

  • Thrombectomy tubing set, non-electronic
The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
ZIEN MEDICAL TECHNOLOGIES, INC.
LR-N-059
In Commercial Distribution

  • B090LRN0591 ()
  • B090LRN0590 ()
  • B090LRN0592 ()

  • Catheter Working Length: 59 Centimeter
  • Introducer Sheath Compatibility: 7 French
LR-N-059

  • Intravascular occluding balloon catheter, image-guided
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-175-H
In Commercial Distribution

  • B090C35175H1 ()
  • B090C35175H0 ()
  • B090C35175H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 175 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-175-H

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135-H
In Commercial Distribution

  • B090C35135H1 ()
  • B090C35135H0 ()
  • B090C35135H2 ()

  • Catheter Gauge: 3.9 French
  • Crossing Profile: 3.2 French
  • Catheter Working Length: 135 Centimeter
  • Introducer Sheath Compatibility: 4 French
C35-135-H

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-135
In Commercial Distribution

  • B090C351351 ()
  • B090C351350 ()
  • B090C351352 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 3.2 French
  • Introducer Sheath Compatibility: 4 French
C35-135

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C35-090-H
In Commercial Distribution

  • B090C35090H1 ()
  • B090C35090H0 ()
  • B090C35090H2 ()

  • Catheter Gauge: 3.9 French
  • Catheter Working Length: 90 Centimeter
  • Introducer Sheath Compatibility: 4 French
  • Crossing Profile: 3.2 French
C35-090-H

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175-H
In Commercial Distribution

  • B090C14175H1 ()
  • B090C14175H0 ()
  • B090C14175H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-175-H

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-175
In Commercial Distribution

  • B090C141751 ()
  • B090C141750 ()
  • B090C141752 ()

  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
  • Catheter Working Length: 175 Centimeter
  • Crossing Profile: 1.6 French
C14-175

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135-H
In Commercial Distribution

  • B090C14135H1 ()
  • B090C14135H0 ()
  • B090C14135H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135-H

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-135
In Commercial Distribution

  • B090C141351 ()
  • B090C141350 ()
  • B090C141352 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 135 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-135

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090-H
In Commercial Distribution

  • B090C14090H1 ()
  • B090C14090H0 ()
  • B090C14090H2 ()

  • Catheter Gauge: 2 French
  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090-H

  • Vascular guide-catheter, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
C14-090
In Commercial Distribution

  • B090C140901 ()
  • B090C140900 ()
  • B090C140902 ()

  • Catheter Working Length: 90 Centimeter
  • Crossing Profile: 1.6 French
  • Catheter Gauge: 2 French
  • Introducer Sheath Compatibility: 2.9 French
C14-090

  • Vascular guide-catheter, single-use
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.”
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1040
In Commercial Distribution

  • B090ASP10401 ()
  • B090ASP10400 ()
  • B090ASP10402 ()
ASP-1040

  • Thrombectomy tubing set, non-electronic
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.”
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1039
In Commercial Distribution

  • B090ASP10391 ()
  • B090ASP10390 ()
  • B090ASP10392 ()
ASP-1039

  • Thrombectomy tubing set, non-electronic
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1036
In Commercial Distribution

  • B090ASP10361 ()
  • B090ASP10360 ()
  • B090ASP10362 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
ASP-1036

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1033
In Commercial Distribution

  • B090ASP10331 ()
  • B090ASP10330 ()
  • B090ASP10332 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
ASP-1033

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The CONTROL MECHANICAL ASPIRATOR is intended to aspirate fluids from the body
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1029
In Commercial Distribution

  • B090ASP10291 ()
  • B090ASP10290 ()
  • B090ASP10292 ()
ASP-1029

  • General-purpose syringe, single-use
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1021
In Commercial Distribution

  • B090ASP10211 ()
  • B090ASP10210 ()
  • B090ASP10212 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
ASP-1021

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
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.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1013
In Commercial Distribution

  • B090ASP10131 ()
  • B090ASP10130 ()
  • B090ASP10132 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
ASP-1013

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1001
In Commercial Distribution

  • B090ASP10011 ()
  • B090ASP10010 ()
  • B090ASP10012 ()

  • Catheter Gauge: 6 French
  • Catheter Length: 136 Centimeter
ASP-1001

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
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