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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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ENT Software with TGS
Stryker Leibinger GmbH & Co. KG
8000-021-002
In Commercial Distribution

  • 07613327514179 ()
8000-021-002

  • Stereotactic system application software
Planning Software
Stryker Leibinger GmbH & Co. KG
8000-021-005
In Commercial Distribution

  • 07613327513950 ()
8000-021-005

  • Stereotactic system application software
ENT Software
Stryker Leibinger GmbH & Co. KG
8000-021-001
In Commercial Distribution

  • 07613327513943 ()
8000-021-001

  • Stereotactic system application software
Scopis ENT Software
Stryker Leibinger GmbH & Co. KG
8000-020-001
In Commercial Distribution

  • 07613327413243 ()
8000-020-001

  • Stereotactic system application software
Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software
No Description
Change Healthcare Canada Company
14.0
In Commercial Distribution

  • 80010939070025 ()


  • Cardiology information system
No Description
Change Healthcare Canada Company
13.2.1
In Commercial Distribution

  • 80010939070018 ()


  • Cardiology information system
The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.8
In Commercial Distribution

  • B057U40140 ()
U4 014

  • Stereotactic system application software
The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.17
In Commercial Distribution

  • B057U4003260170 ()
U4 003

  • Stereotactic system application software
The Navigation Software NOCA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy.
Scopis GmbH
2.6.16
In Commercial Distribution

  • B057U4003260160 ()
U4 003

  • Stereotactic system application software
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