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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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No Description
COCHLEAR LIMITED
Z50101
In Commercial Distribution

  • 09321502002783 ()


  • Cochlear implant implantable magnet
No Description
Advanced Bionics AG
CI-1413
Not in Commercial Distribution

  • 07630016860652 ()


  • Cochlear implant implantable magnet
No Description
Advanced Bionics AG
CI-1419
Not in Commercial Distribution

  • 07630016854163 ()


  • Cochlear implant implantable magnet
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
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
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
Alpha-Stim AID kit - China
Electromedical Products International, Inc.
AID
In Commercial Distribution

  • 00857869005017 ()
500

  • 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
PreFace abutment incl. abutment screw
MEDENTiKA GmbH
I 9020-16R-ET
In Commercial Distribution

  • 04251574850843 ()

  • compatible with BIOMET 3i / External Hex; D 5.0
I 9020-16R-ET

  • Dental implant suprastructure, permanent, preformed
PreFace abutment incl. abutment screw
MEDENTiKA GmbH
I 9010-R-ET
In Commercial Distribution

  • 04251574850836 ()

  • compatible with BIOMET 3i / External Hex; D 4.1
I 9010-R-ET

  • Dental implant suprastructure, permanent, preformed
PreFace abutment incl. abutment screw
MEDENTiKA GmbH
I 9000-R-ET
In Commercial Distribution

  • 04251574850829 ()

  • compatible with BIOMET 3i / External Hex; D 3.4
I 9000-R-ET

  • Dental implant suprastructure, permanent, preformed
TI-Forms-Abutment for M-Series incl. Screw
MEDENTiKA GmbH
I 9020-ST
In Commercial Distribution

  • 04251574819215 ()
  • EMKAI9020ST9 ()

  • compatible with BIOMET 3i / External Hex; D 5,0
I 9020-ST

  • Dental implant suprastructure, permanent, preformed
TI-Forms-Abutment for Ceramill incl. Screw
MEDENTiKA GmbH
I 9020-AG
In Commercial Distribution

  • 04251574819208 ()
  • EMKAI9020AG9 ()

  • compatible with BIOMET 3i / External Hex; D 5,0
I 9020-AG

  • Dental implant suprastructure, permanent, preformed
PreFace abutment incl. Screw
MEDENTiKA GmbH
I 9020-16R
In Commercial Distribution

  • EMKAI902016R9 ()
  • 04251574819192 ()

  • compatible with BIOMET 3i / External Hex; D 5,0
I 9020-16R

  • Dental implant suprastructure, permanent, preformed
TI-Forms-Abutment for M-Series incl. Screw
MEDENTiKA GmbH
I 9010-ST
In Commercial Distribution

  • 04251574819185 ()
  • EMKAI9010ST9 ()

  • compatible with BIOMET 3i / External Hex; RP 4,1
I 9010-ST

  • Dental implant suprastructure, permanent, preformed
PreFace abutment incl. Screw
MEDENTiKA GmbH
I 9010-R
In Commercial Distribution

  • EMKAI9010R9 ()
  • 04251574819178 ()

  • compatible with BIOMET 3i / External Hex; D 4,1
I 9010-R

  • Dental implant suprastructure, permanent, preformed
TI-Forms-Abutment for Ceramill incl. Screw
MEDENTiKA GmbH
I 9010-AG
In Commercial Distribution

  • 04251574819161 ()
  • EMKAI9010AG9 ()

  • compatible with BIOMET 3i / External Hex; RP 4,1
I 9010-AG

  • Dental implant suprastructure, permanent, preformed
TI-Forms-Abutment for M-Series incl. Screw
MEDENTiKA GmbH
I 9000-ST
In Commercial Distribution

  • 04251574819154 ()
  • EMKAI9000ST9 ()

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

  • Dental implant suprastructure, permanent, preformed
PreFace abutment incl. Screw
MEDENTiKA GmbH
I 9000-R
In Commercial Distribution

  • EMKAI9000R9 ()
  • 04251574819147 ()

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

  • Dental implant suprastructure, permanent, preformed
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
MedentiBASE abutment
MEDENTiKA GmbH
I 4210
In Commercial Distribution

  • 04251574818836 ()
  • EMKAI42109 ()

  • compatible with BIOMET 3i / External Hex; D 4,1
I 4210

  • Dental implant suprastructure, permanent, preformed
MedentiBASE abutment
MEDENTiKA GmbH
I 4200
In Commercial Distribution

  • 04251574818829 ()
  • EMKAI42009 ()

  • compatible with BIOMET 3i / External Hex; D 3,4
I 4200

  • Dental implant suprastructure, permanent, preformed
MedentiBASE abutment
MEDENTiKA GmbH
I 4110
In Commercial Distribution

  • 04251574818805 ()
  • EMKAI41109 ()

  • compatible with BIOMET 3i / External Hex; D 4,1
I 4110

  • Dental implant suprastructure, permanent, preformed
MedentiBASE abutment
MEDENTiKA GmbH
I 4100
In Commercial Distribution

  • 04251574818799 ()
  • EMKAI41009 ()

  • compatible with BIOMET 3i / External Hex; D 3,4
I 4100

  • Dental implant suprastructure, permanent, preformed
MedentiBASE abutment
MEDENTiKA GmbH
I 4010
In Commercial Distribution

  • 04251574818775 ()
  • EMKAI40109 ()

  • compatible with BIOMET 3i / External Hex; D 4,1
I 4010

  • Dental implant suprastructure, permanent, preformed
MedentiBASE abutment
MEDENTiKA GmbH
I 4000
In Commercial Distribution

  • 04251574818768 ()
  • EMKAI40009 ()

  • compatible with BIOMET 3i / External Hex; D 3,4
I 4000

  • Dental implant suprastructure, permanent, preformed
Temporary abutment incl. Screw
MEDENTiKA GmbH
I 3510
In Commercial Distribution

  • 04251574818744 ()
  • EMKAI35109 ()

  • compatible with BIOMET 3i / External Hex; D 4,1
I 3510

  • Dental implant suprastructure, permanent, preformed
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