STM9000 FAST

GUDID 08056446900772

Magnetic neural stimulation system. (Power supply voltage: 230VAC).

EB NEURO SPA

Magnetic neural stimulation system, stationary
Primary Device ID08056446900772
NIH Device Record Keyc5ede9c1-41d3-4067-9e20-991bc8809bf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTM9000 FAST
Version Model NumberB9800086014
Company DUNS339182263
Company NameEB NEURO SPA
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

Phone+390554565111
Emailinfo@ebneuro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108056446900772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFStimulator, Electrical, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-03
Device Publish Date2019-05-24

On-Brand Devices [STM9000 FAST]

08056446900840Magnetic neural stimulation equipment. (Power supply voltage: 230VAC).
08056446900772Magnetic neural stimulation system. (Power supply voltage: 230VAC).
08056446900536Magnetic neural stimulation equipment. (Power supply voltage: 115VAC).
08056446900468Magnetic neural stimulation system. (Power supply voltage: 115VAC).

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