Recording and stimulating for Central Nervous System electrodes

GUDID 18054655026815

SPES MEDICA SRL

Cortical electrode

• Primary Device ID: 18054655026815
• NIH Device Record Key: f0191e80-96b2-4f45-82c4-2e532759e748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Recording and stimulating for Central Nervous System electrodes
• Version Model Number: IEP0007
• Company DUNS: 514029771
• Company Name: SPES MEDICA SRL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054655026815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211954

FDA Product Code

• GYC: Electrode, Cortical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Recording and stimulating for Central Nervous System electrodes]

• 18054655028239: IEP0006
• 18054655028222: IEP0008
• 18054655026815: IEP0007