CloudTMS Edge for OCD

GUDID 04650075335895

The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)

NEUROSOFT, OOO

Magnetic neural stimulation system
Primary Device ID04650075335895
NIH Device Record Key7b9d1265-c341-48c6-a785-fbd6a0e77a85
Commercial Distribution StatusIn Commercial Distribution
Brand NameCloudTMS Edge for OCD
Version Model NumberMain unit
Company DUNS643212926
Company NameNEUROSOFT, OOO
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com
Phone617 8403253
EmailJjabre@teleemg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075335895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-22
Device Publish Date2024-01-12

On-Brand Devices [CloudTMS Edge for OCD]

04650075335949No description
04650075335895The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult pat

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