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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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Alpha-Stim SCS kit
Electromedical Products International, Inc.
SCS
In Commercial Distribution

  • 00857869005208 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Alpha-Stim AID kit - China
Electromedical Products International, Inc.
AID
In Commercial Distribution

  • 00857869005017 ()
500

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.
INNOVATIVE NEUROLOGICAL DEVICES LLC
Cervella CES
In Commercial Distribution

  • 00860001493306 ()
Cervella

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Cranial Electrotherapy Stimulator
NEURO-FITNESS LLC
AR635A
In Commercial Distribution

  • M750AR635A0 ()
CES-Ultra

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Cranial Electrotherapy Stimulator
NEURO-FITNESS LLC
AR635A
In Commercial Distribution

  • M750AR635A ()
CES-Ultra

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38303
In Commercial Distribution

  • 09008737383039 ()


  • Cochlear implant system external kit
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38301
In Commercial Distribution

  • 09008737383015 ()


  • Cochlear implant system external kit
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38584
In Commercial Distribution

  • 09008737385842 ()


  • Cochlear implant system external kit
Audio Processor Accessory
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
38302
In Commercial Distribution

  • 09008737383022 ()


  • Cochlear implant system external kit
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007196 ()


  • Penile vacuum device
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