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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ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021532 ()
03417

  • Peripheral vascular haemodynamic measurement application software
IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS). It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure.
Centerline Biomedical, Inc.
T02111
In Commercial Distribution

  • 10843152103024 ()
  • 00843152103027 ()
T02111

  • Electromagnetic surgical navigation device tracking system
IOPS™ Tracking Pad 1
Centerline Biomedical, Inc.
TP-1
In Commercial Distribution

  • 10843152103000 ()
  • 00843152103003 ()
TP-1

  • Electromagnetic surgical navigation device tracking system
Guidewire Handle
Centerline Biomedical, Inc.
H01035
In Commercial Distribution

  • 10843152102058 ()
  • 00843152102051 ()
H01035

  • Electromagnetic surgical navigation device tracking system
Indications for Use: The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis. IOPS™ Guidewire 2 is a sensorized wire used to navigate through vasculature to facilitate placement of a catheter. The guidewire is a single-use, externally communicating device that comes into contact with circulating blood for a duration of less than or equal to 24 hours.
Centerline Biomedical, Inc.
ATW-2
In Commercial Distribution

  • 10843152102034 ()
  • 00843152102037 ()
ATW-2

  • Cardiac/peripheral vascular guidewire, single-use
IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
Centerline Biomedical, Inc.
SSH-1
In Commercial Distribution

  • 10843152102010 ()
  • 00843152102013 ()
SSH-1

  • Cardiac/peripheral vascular guidewire, single-use
IOPS™ Catheter Reverse Curve 1
Centerline Biomedical, Inc.
RCC-1
In Commercial Distribution

  • 10843152101037 ()
  • 00843152101030 ()
RCC-1

  • Vascular guide-catheter, single-use
IOPS™ Catheter Simple Curve 1
Centerline Biomedical, Inc.
SCC-1
In Commercial Distribution

  • 10843152101020 ()
  • 00843152101023 ()
SCC-1

  • Vascular guide-catheter, single-use
Guidewire
GALT MEDICAL CORP.
SGW-011-08
In Commercial Distribution

  • 00841268100541 ()
  • 10841268100548 ()
  • 20841268100545 ()

  • Outer Diameter: 0.035 Inch
SGW-011-08

  • Peripheral vascular guidewire, manual
No Description
Biosense Webster Inc
D128623
Not in Commercial Distribution

  • 10846835008890 ()
D128623

  • Electrical-only medical device connection cable, reusable
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