Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz

GUDID 08056446900659

Isolation Transformer for EEG/EMG/EP systems

EB NEURO SPA

Constant-voltage transformer
Primary Device ID08056446900659
NIH Device Record Key7fcc57bb-bb88-464e-8350-efed3fea45de
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsolation Transformer ‘GP’ 110-120 VAC 50/60 Hz
Version Model NumberB9700041001
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
GS108056446900659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKNElectromyograph, Diagnostic

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

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08056446900048 - BE Micro PLUG-IN HEADBOX2019-11-08 Patient-interface for EEG ambulatory recorder
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