Neurosign 800

GUDID 05060229530103

Intraoperative nerve monitor

THE MAGSTIM COMPANY LIMITED

Nerve-locating system
Primary Device ID05060229530103
NIH Device Record Key0bd3c820-c411-4f85-8fc9-fe8b333208fe
Commercial Distribution Discontinuation2018-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNeurosign 800
Version Model Number1402-00
Company DUNS500375274
Company NameTHE MAGSTIM COMPANY LIMITED
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+441994240798
EmailQA.RA@magstim.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060229530103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETNStimulator, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-12-31
Device Publish Date2016-09-23

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