Nurochek-Pro Soft Sensor Kit HS03-313

GUDID 09357225003028

The Nurochek-Pro Soft Sensor Kit is a non-invasive accessory intended for use with the Nurochek-Pro headset. The kit contains soft sensor components designed to interface with the Nurochek-Pro headset to support EEG acquisition. The Soft Sensor Kit has no independent diagnostic or therapeutic function and is not intended to be used on a standalone basis. The accessory is supplied non-sterile and is intended for use by healthcare professionals in accordance with the Nurochek-Pro system Instructions for Use

HEADSAFE MFG PTY LTD

Evoked-potential graphic recording system
Primary Device ID09357225003028
NIH Device Record Key5357db65-d626-46c6-9931-fd0a5137c5fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameNurochek-Pro Soft Sensor Kit
Version Model NumberNurochek-Pro Soft Sensor Kit (HS03-313)
Catalog NumberHS03-313
Company DUNS748905226
Company NameHEADSAFE MFG PTY LTD
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+61413133492
Emailsupport@team.headsafe.com
Phone+61413133492
Emailsupport@team.headsafe.com
Phone+61413133492
Emailsupport@team.headsafe.com
Phone+61413133492
Emailsupport@team.headsafe.com
Phone+61413133492
Emailsupport@team.headsafe.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109357225003028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

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