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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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OrthoGrid Trauma AI for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-507
In Commercial Distribution

  • 00860003424841 ()


  • Orthopaedic fluoroscopic grid software
OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-505
In Commercial Distribution

  • 00860003424834 ()


  • Orthopaedic fluoroscopic grid software
OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-502
In Commercial Distribution

  • 00860003424827 ()


  • Orthopaedic fluoroscopic grid software
OrthoGrid Hip Preservation 3.0 non-invasive software system that provides image analysis tools for Hip Preservation.
Orthogrid Systems, Inc.
4015-915-501
In Commercial Distribution

  • 00860003424810 ()


  • Orthopaedic fluoroscopic grid software
OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-504
In Commercial Distribution

  • 00860003424803 ()


  • Orthopaedic fluoroscopic grid software
Version 6.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Version 7.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.
Surgical Information Sciences Inc.
6.X.X, 7.X.X
In Commercial Distribution

  • 00860001580907 ()


  • Stereotactic system application software
OASIS NXT 2020.1 COSTCO
Bernafon AG
214707
In Commercial Distribution

  • 05711584115862 ()


  • Audiometric/hearing device software
OASIS NXT 2020.1
Bernafon AG
214706
In Commercial Distribution

  • 05711584115855 ()


  • Audiometric/hearing device software
OASIS NXT 2020.1 CUSTOM
Bernafon AG
214705
In Commercial Distribution

  • 05711584115848 ()


  • Audiometric/hearing device software
OASIS NXT 2019.2 CUSTOM
Bernafon AG
204542
In Commercial Distribution

  • 05711584106563 ()


  • Audiometric/hearing device software
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