ResponseGrip Interface

GUDID 07090042054041

ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PC 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

Medical networking interface unit

• Primary Device ID: 07090042054041
• NIH Device Record Key: 989deb0f-236f-4168-a226-dacd1a218809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResponseGrip Interface
• Version Model Number: RGI-2.2
• Company DUNS: 671280238
• Company Name: Nordicneurolab AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com
• Phone: +4755707095
• Email: ProductSolutions@nordicneurolab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090042054041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092253

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [ResponseGrip Interface]

• 07090042054027: ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips an
• 07090042054041: ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips an