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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 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
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