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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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The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000356 ()
10185571000356

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000349 ()
10185571000349

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000332 ()
10185571000332

  • Pressure monitoring insole
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000172 ()
10185571000172

  • Pressure monitoring insole
No Description
Osstell AB
Osstell OsstellConnect
In Commercial Distribution

  • 09010522001073 ()


  • Dental treatment application software
No Description
COCHLEAR LIMITED
Osia 2 System
In Commercial Distribution

  • 09321502045124 ()
P1343785

  • Hearing implant system sound processor activation kit
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software
Intra Oral Camera, Direct-USB, Auto-Focus
Beyes Dental Canada Inc
EV2060
In Commercial Distribution

  • 00628504370056 ()


  • Intraoral camera
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
Not in Commercial Distribution

  • 00850023296351 ()
Shoe insole size 4 (men 13.0 to 15.0)

  • Pressure monitoring insole
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