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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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MR-RT - 00884838112742

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
300005806303
In Commercial Distribution

  • 00884838112742 ()
781439

  • MRI system application software

LumiGuide - 00884838112087

Visualization device with FORS technology intended to aid the positioning and navigation of a connected LumiGuide Wire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected LumiGuide Wire, and of an endovascular catheter, when combined with a LumiGuide 3D Hub.
Philips Medical Systems Nederland B.V.
LumiGuide Equipment
In Commercial Distribution

  • 00884838112087 ()
NCVC933

  • Diagnostic x-ray digital imaging system workstation application software

AltaTrack - 00884838099340

Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
Philips Medical Systems Nederland B.V.
AltaTrack equipment
Not in Commercial Distribution

  • 00884838099340 ()
4322 070 2535 X

  • Diagnostic x-ray digital imaging system workstation application software

MR-RT - 00884838094093

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain)
Philips Oy
MRCAT Brain / RTgo 4.0
In Commercial Distribution

  • 00884838094093 ()
781439

  • MRI system application software

RTgo - 00884838092112

MR-RT RTgo software USB stick
Philips Oy
459801266633
In Commercial Distribution

  • 00884838092112 ()


  • MRI system application software

cvi42 - 00882916000011

No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software

cvi42 - 00882916000004

Cardiac MR & CT imaging software application
Circle Cardiovascular Imaging Inc
5.6
In Commercial Distribution

  • 00882916000004 ()


  • MRI system application software

CARDINAL HEALTH - 10195594198589

LAPAROSCOPY PACK II
Cardinal Health 200, LLC
SBA23LPHM2
In Commercial Distribution

  • 50195594198587 ()
  • 10195594198589 ()
SBA23LPHM2

  • Decontamination floor mat, single-use

ScanPoint® - 00879123006134

No Description
VERATHON INC
QuickPrint
In Commercial Distribution

  • 00879123006134 ()
0900-1238

  • Ultrasound imaging system application software

ScanPoint® - 00879123006127

No Description
VERATHON INC
ScanPoint®
In Commercial Distribution

  • 00879123006127 ()


  • Ultrasound imaging system application software
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