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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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OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DT
In Commercial Distribution

  • 05060396173134 ()


  • Otoacoustic emission system, battery-powered
OtoNova Pro system for TEOAE, DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DPTE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DTA
In Commercial Distribution

  • 05060396173165 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 18", 1 temperature probe, 2 CO2 canisters 2.5lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258415 ()


  • Laboratory refrigerator/freezer
Cooling device using CO2 as coolant, powered by Li-Ion battery. Cooling plate 13", 1 temperature probe, 2 CO2 canisters 1lb/each, Bluetooth module to communicate with an App
FROSTIME LLC
V 1.0
In Commercial Distribution

  • 00860003258408 ()


  • Laboratory refrigerator/freezer
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
Evok 1600 Wireless
In Commercial Distribution

  • 00851362008070 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX8
In Commercial Distribution

  • 00851362008056 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating Bluetooth Low Energy protocol to be controlled with RxEars APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,.
Persona Medical
RxEars RX7
In Commercial Distribution

  • 00851362008018 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
ALYK, INC.
Personal Lubricant - .COM
In Commercial Distribution

  • 00851617007872 ()


  • General-body orifice lubricant, non-sterile
No Description
MICROPORT CRM SRL
V3.10 USB COM
In Commercial Distribution

  • 08031527014296 ()


  • Electrocardiographic long-term ambulatory recording analyser
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