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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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MOTOR 560A EXTERNAL DRIVE SHORT PLX
MEDTRONIC, INC.
560A
In Commercial Distribution

  • 00763000108298 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit
MOTOR 560A EXTERNAL DRIVE LONG PLX
MEDTRONIC, INC.
560A
In Commercial Distribution

  • 00763000108281 ()


  • Cardiopulmonary bypass system centrifugal pump drive unit
HANDCRANK HC150A PLX
MEDTRONIC, INC.
HC150A
In Commercial Distribution

  • 00763000108274 ()


  • Centrifugal circulatory assist pump, manual
CONSOLE PTEYE
MEDTRONIC XOMED, INC.
PTEYE
In Commercial Distribution

  • 00763000497040 ()


  • Intraoperative parathyroid detection system control unit
Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each. The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments. The Nerivio Infinity package under this UDI contains 1 refill unit.
Theranica Bio-Electronics Ltd.
FGD000100
In Commercial Distribution

  • 07290017578118 ()
FGD000100

  • Craniofacial analgesia electrical stimulator
Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each. The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments. The Nerivio Infinity package under this UDI contains 3 refill units.
Theranica Bio-Electronics Ltd.
FGD000100
In Commercial Distribution

  • 07290017578101 ()
FGD000100

  • Craniofacial analgesia electrical stimulator
Refill pack for Nerivio device
Theranica Bio-Electronics Ltd.
FGD000075
In Commercial Distribution

  • 07290017578026 ()


  • Craniofacial analgesia electrical stimulator
Nerivio is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]). Nerivio is a wireless wearable battery-operated device controlled by a mobile software application. The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
Theranica Bio-Electronics Ltd.
FGD000075
In Commercial Distribution

  • 07290017578019 ()


  • Craniofacial analgesia electrical stimulator
Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
ST 200E
In Commercial Distribution

  • 06973993442222 ()


  • Intraoral optical scanning system
No Description
ONWARD Medical N.V.
ARC-EX System - Professional US
In Commercial Distribution

  • 08720908310040 ()
  • 08720908310002 ()
EXSYS01PROUS

  • Spinal cord rehabilitation transcutaneous electrical stimulation system
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