ResponseGrips

GUDID 07090042054010

The ResponseGrip is an MRI-safe patient response device, providing real-time feedback of a patient response. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.

Nordicneurolab AS

Interactive-evaluation patient hand-controller
Primary Device ID07090042054010
NIH Device Record Key1f407c5e-995b-43a3-b712-038aa6fb8d0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameResponseGrips
Version Model Number4.0
Company DUNS671280238
Company NameNordicneurolab AS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com
Phone+4755707095
EmailProductSolutions@nordicneurolab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107090042054010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-28
Device Publish Date2017-05-22

Devices Manufactured by Nordicneurolab AS

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07090042052115 - Visual System HD2025-03-12 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente
07090042059084 - nordicMEDIVA2024-11-07 nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pi
07090042059077 - nordicMEDIVA2024-07-23 nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pi
07090042059053 - nordicDSC2024-02-20 nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility cont
07090042059046 - nordicDSC2022-09-21
07090042052078 - VisualSystem Power Cable (VPC)2021-02-08 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente
07090042052108 - Visual System HD2021-02-08 The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presente

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