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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Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder
Arial Mobile App
Securitas Healthcare LLC
54600
In Commercial Distribution

  • 00840948100963 ()


  • Alarm application software
Insulin Titration App
Sanofi-Aventis Deutschland GmbH
2.x.x
Not in Commercial Distribution


  • No size - Software as a Medical Device
N/A

  • Clinical management support software
MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder
Therapy Controller App
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5275
In Commercial Distribution

  • 00191506020705 ()


  • Implantable spinal cord electrical stimulation system programmer
Support App (Palma)
Advanced Bionics, LLC
CI-6517
In Commercial Distribution

  • 00840094491007 ()


  • Audiometric/hearing device software
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