STM9000 FAST_BI

GUDID 08056446900543

Magnetic neural stimulation equipment. (Power supply voltage: 115VAC).

EB NEURO SPA

Magnetic neural stimulation system, stationary

• Primary Device ID: 08056446900543
• NIH Device Record Key: c09f38f2-6f0c-4cb0-bf0b-c9323da9342d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STM9000 FAST_BI
• Version Model Number: B9700086250
• Company DUNS: 339182263
• Company Name: EB NEURO SPA
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: true
• 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: +390554565111
• Email: info@ebneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056446900543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150220

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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: 2019-06-03
• Device Publish Date: 2019-05-24

On-Brand Devices [STM9000 FAST_BI ]

• 08056446900857: Magnetic neural stimulation equipment. (Power supply voltage: 230VAC).
• 08056446900789: Magnetic neural stimulation system. (Power supply voltage: 230VAC).
• 08056446900543: Magnetic neural stimulation equipment. (Power supply voltage: 115VAC).
• 08056446900475: Magnetic neural stimulation system. (Power supply voltage: 115VAC).