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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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ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-055
Not in Commercial Distribution

  • B090A50552 ()
  • B090A50551 ()
  • B090A50550 ()
A5-055

  • 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.
A11-090
In Commercial Distribution

  • B090A110901 ()
  • B090A110900 ()
  • B090A110902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
A11-090

  • 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.
A11-060
In Commercial Distribution

  • B090A110601 ()
  • B090A110600 ()
  • B090A110602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
A11-060

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
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.
5X-GW
In Commercial Distribution

  • B0905XGW1 ()
  • B0905XGW0 ()
  • B0905XGW2 ()
5X-GW

  • Torque manipulation device
The Control Mechanical Aspirator is intended to aspirate fluids from the body.
ZIEN MEDICAL TECHNOLOGIES, INC.
30-ASP
In Commercial Distribution

  • B09030ASP0 ()
  • B09030ASP1 ()
  • B09030ASP2 ()
30-ASP

  • General-purpose syringe, single-use
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-S
In Commercial Distribution

  • B0902P0130S1 ()
  • B0902P0130S0 ()
  • B0902P0130S2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-S

  • Vascular microcatheter
The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
ZIEN MEDICAL TECHNOLOGIES, INC.
2P0-130-B
In Commercial Distribution

  • B0902P0130B1 ()
  • B0902P0130B0 ()
  • B0902P0130B2 ()

  • Catheter Length: 130 Centimeter
  • Catheter Gauge: 2 French
2P0-130-B

  • Vascular microcatheter
CryoPRO™-5 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0442
In Commercial Distribution

  • B039SGI04421 ()
  • B039SGI04420 ()
  • B039SGI04429 ()


  • Blood cell freeze/thaw system
SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set
CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system
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