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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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Software medical device, used with a Philips Interventional X-Ray System. Assists the user with treatment of structural heart diseases using minimal invasive interventional techniques.
Philips Medical Systems Nederland B.V.
HeartNavigator - 3
In Commercial Distribution

  • 00884838080744 ()
001001

  • Angiographic x-ray 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 - 3
In Commercial Distribution

  • 00884838080737 ()
001011

  • Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Provides quantitative information about coronary arteries, peripheral arteries, and ventricles.
Philips Medical Systems Nederland B.V.
2D Quantitative Analysis - 1
In Commercial Distribution

  • 00884838075863 ()
001014

  • Angiographic x-ray system application software
67-2586-0100-01 is an electronic file. There is no packaging.
ICU MEDICAL, INC.
67-2586-0100-01
In Commercial Distribution

  • 15019517130928 ()

  • Outer Diameter: 0 Millimeter
  • Length: 0 Millimeter
  • Width: 0 Millimeter
  • Circumference: 0 Millimeter
  • 0
  • Depth: 0 Millimeter


  • Infusion pump medication-dosage application software
No Description
Biomet Orthopedics, LLC
CG006
In Commercial Distribution

  • 00880304990050 ()
CG006

  • Orthopaedic/craniofacial implantation planning software
No Description
Biomet Orthopedics, LLC
CG005
In Commercial Distribution

  • 00880304990043 ()
CG005

  • Orthopaedic/craniofacial implantation planning software
No Description
Biomet Orthopedics, LLC
CG004
In Commercial Distribution

  • 00880304990036 ()
CG004

  • Orthopaedic/craniofacial implantation planning software
No Description
Biomet Orthopedics, LLC
CG003
In Commercial Distribution

  • 00880304990029 ()
CG003

  • Orthopaedic/craniofacial implantation planning software
No Description
Biomet Orthopedics, LLC
CG002
In Commercial Distribution

  • 00880304990012 ()
CG002

  • Orthopaedic/craniofacial implantation planning software
No Description
Biomet Orthopedics, LLC
CG001
In Commercial Distribution

  • 00880304990005 ()
CG001

  • Orthopaedic/craniofacial implantation planning software
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