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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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TI-Forms-Abutment for Ceramill incl. Screw
MEDENTiKA GmbH
I 9000-AG
In Commercial Distribution

  • 04251574819130 ()
  • EMKAI9000AG9 ()

  • compatible with BIOMET 3i / External Hex; D 3,4
I 9000-AG

  • Dental implant suprastructure, permanent, preformed
Alpha-Stim AID kit - US
Electromedical Products International, Inc.
AID
In Commercial Distribution

  • 00857869005260 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
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
Modius Calm is a non-invasive, home-use neurostimulation device that is indicated to treat Generalized Anxiety Disorder (GAD) in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
NEUROVALENS LIMITED
MA1500
In Commercial Distribution

  • 05070002841210 ()


  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
NEUROVALENS LIMITED
MS1000
In Commercial Distribution

  • 05070002841203 ()


  • 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
Hemostatic Gauze Pads: The device is indicated for: temporary external use to control moderate to severe bleeding. Hemostatic gauze is for temporary external use only
MEDTRADE PRODUCTS LIMITED
FG08834291
In Commercial Distribution

  • 35060206630162 ()
  • 15060206630168 ()
  • 75060206630160 ()
  • 25060206630165 ()

  • Two 4in by 4in dressing pads per supplied folded 2in x20in
  • Length: 4 Inch
  • Width: 4 Inch
FG08834291

  • Chitosan haemostatic agent, professional, non-bioabsorbable
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