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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WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.2
In Commercial Distribution

  • B148WSONE1820 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.1
In Commercial Distribution

  • B148WSONE1810 ()


  • Radiology picture archiving and communication system workstation
The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass .023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature.
Vascular Solutions, Inc.
5230
Not in Commercial Distribution

  • M20652300 ()

  • Length: 135 Centimeter
  • Catheter Gauge: 4 French


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P35-60-150
In Commercial Distribution

  • M781P35601501 ()

  • Sheath Compatibility: 6 Fr
  • Shaft Length: 150 cm
  • Tracking Length: 60 mm
  • Guide Wire Compatibility: 0.035”


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P35-40-150
In Commercial Distribution

  • M781P35401501 ()

  • Sheath Compatibility: 6 Fr
  • Shaft Length: 150 cm
  • Tracking Length: 40 mm
  • Guide Wire Compatibility: 0.035”


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P35-20-150
In Commercial Distribution

  • M781P35201501 ()

  • Shaft Length: 150 cm
  • Tracking Length: 20 mm
  • Guide Wire Compatibility: 0.035”
  • Sheath Compatibility: 6 Fr


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P35-120-170
In Commercial Distribution

  • M781P351201701 ()

  • Sheath Compatibility: 6 Fr
  • Shaft Length: 170 cm
  • Tracking Length: 120 mm
  • Guide Wire Compatibility: 0.035”


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P35-120-150
In Commercial Distribution

  • M781P351201501 ()

  • Shaft Length: 150 cm
  • Tracking Length: 120 mm
  • Guide Wire Compatibility: 0.035”
  • Sheath Compatibility: 6 Fr


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P18-60-150
In Commercial Distribution

  • M781P18601501 ()

  • Sheath Compatibility: 6 Fr
  • Shaft Length: 150 cm
  • Tracking Length: 60 mm
  • Guide Wire Compatibility: 0.018”


  • Peripheral vascular intervention infusion catheter
The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.
Thermopeutix, Inc.
P18-40-150
In Commercial Distribution

  • M781P18401501 ()

  • Sheath Compatibility: 6 Fr
  • Shaft Length: 150 cm
  • Tracking Length: 40 mm
  • Guide Wire Compatibility: 0.018”


  • Peripheral vascular intervention infusion catheter
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