R-KEY (Dedicated Keyboard)

GUDID 08056446900260

Interface for EMG/EP Amplifier

EB NEURO SPA

Evoked-potential graphic recording system
Primary Device ID08056446900260
NIH Device Record Key1e2a7321-6a5c-4758-86fa-bbb4408174cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameR-KEY (Dedicated Keyboard)
Version Model NumberB9700051000
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
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com
Phone+390554565111
Emailinfo@ebneuro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108056446900260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXEDevice, Nerve Conduction Velocity Measurement

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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08056446900901 - BE PLUS PRO STANDARD2024-12-12 Acquisition unit
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