Nurochek-Pro Saline Solution HS03-368

GUDID 09357225006029

The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The solution is used to support electrical contact between the Nurochek-Pro headset sensors and the skin during device operation. The saline solution has no independent diagnostic or therapeutic function and is not intended to be used on a standalone basis. The product is supplied 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 ID09357225006029
NIH Device Record Key276a40d1-1646-4412-81f8-89628c478f74
Commercial Distribution StatusIn Commercial Distribution
Brand NameNurochek-Pro Saline Solution
Version Model NumberSaline Solution Bottle Assembly (HS03-368)
Catalog NumberHS03-368
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 Datetrue
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
GS109357225006029 [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

Devices Manufactured by HEADSAFE MFG PTY LTD

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09357225006029 - Nurochek-Pro Saline Solution2025-12-23The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The solution is used to support electrical contact between the Nurochek-Pro headset sensors and the skin during device operation. The saline solution has no independent diagnostic or therapeutic function and is not intended to be used on a standalone basis. The product is supplied for use by healthcare professionals in accordance with the Nurochek-Pro system Instructions for Use.
09357225006029 - Nurochek-Pro Saline Solution2025-12-23 The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The so
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