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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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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.
C14-135-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
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 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 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
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