tracking tools

GUDID B195NT115

StimGuide component

eemagine Medical Imaging Solutions GmbH

Stereotactic neuronavigation/planning system

• Primary Device ID: B195NT115
• NIH Device Record Key: e87b0bd7-fcfd-4e99-a9db-ab034bf738ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tracking tools
• Version Model Number: NT-115
• Company DUNS: 313152485
• Company Name: eemagine Medical Imaging Solutions GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +493029048404
• Email: support@eemagine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B195NT115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183376

FDA Product Code

• HAW: Neurological stereotaxic Instrument

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: 2019-06-24
• Device Publish Date: 2019-06-14

On-Brand Devices [tracking tools]

• B195NT150: StimGuide component
• B195NT149: StimGuide component
• B195NT115: StimGuide component
• B195NT103: StimGuide component
• B195NT105: visor2 component
• B195NT159: visor2 component
• B195NT158: visor2 component
• B195NT157: visor2 component
• B195NT148: visor2 component
• B195NT143: visor2 component
• B195NT134: visor2 component
• B195NT133: visor2 component
• B195NT126: visor2 component
• B195NT125: visor2 component
• B195NT124: visor2 component
• B195NT123: visor2 component
• B195NT120: visor2 component
• B195NT118: visor2 component
• B195NT117: visor2 component
• B195NT112: visor2 component
• B195NT109: visor2 component
• B195NT106: visor2 component
• B195NT1041: visor2 component
• B195NT1040: visor2 component