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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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First Responder Burn Wrap 3'x2.5', 4 Pouches/cs; BD Gel HA
WATER-JEL TECHNOLOGIES, L.L.C.
G3630P-4.00.000
In Commercial Distribution

  • 00743537000517 ()
  • 00743537000074 ()
G3630P-4.00.000

  • Pure wool burn sheet
BurnFree 96"X60", 244x152cm Fire/Trauma Blanket
WATER-JEL TECHNOLOGIES, L.L.C.
SB-244152.00.000
In Commercial Distribution

  • 00743537000050 ()
SB-244152.00.000

  • Pure wool burn sheet
First Responder Burn Wrap 3'x2.5', Canister 4/cs
WATER-JEL TECHNOLOGIES, L.L.C.
G3630C-4.00.000
In Commercial Distribution

  • 00743537000036 ()
  • 00743537000500 ()
G3630C-4.00.000

  • Pure wool burn sheet
BurnFree 72"X60", 183x152cm Fire/Trauma Blanket
WATER-JEL TECHNOLOGIES, L.L.C.
SB-183152.00.000
In Commercial Distribution

  • 00743537000005 ()
SB-183152.00.000

  • Pure wool burn sheet
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.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software
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
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
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 Oy
RTgo 5.0 5
Not in Commercial Distribution

  • 00884838107311 ()
300005806302

  • MRI system application software
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
UroNav 4
In Commercial Distribution

  • 00884838107069 ()
784039

  • Ultrasound imaging system application software
Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Philips Medical Systems Nederland B.V.
EchoNavigator - 4
In Commercial Distribution

  • 00884838106437 ()


  • Angiographic x-ray system application software
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