SAC2 - Electrode Cream

GUDID 18054655027157

SPES MEDICA SRL

Electrode conductive medium

• Primary Device ID: 18054655027157
• NIH Device Record Key: 9ea9bb2c-dad0-465c-b952-a8a8a1a19335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAC2 - Electrode Cream
• Version Model Number: SAC2-10
• Company DUNS: 514029771
• Company Name: SPES MEDICA SRL
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	08054655027150 [Unit of Use]
GS1	18054655027157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192606

FDA Product Code

• GYB: Media, Electroconductive

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: 2020-02-04
• Device Publish Date: 2020-01-27

Devices Manufactured by SPES MEDICA SRL

• 18054655026815 - Recording and stimulating for Central Nervous System electrodes: 2022-12-07
• 18054655028222 - Recording and stimulating for Central Nervous System electrodes: 2022-12-07
• 18054655028239 - Recording and stimulating for Central Nervous System electrodes: 2022-12-07
• 18054655000402 - Connection cable: 2021-12-30
• 08054655023664 - AC Cream - Conductive Paste: 2021-12-30
• 08054655031843 - SafePrep: 2021-08-13
• 18054655025979 - Urethral Catheter Electrode: 2021-06-01
• 18054655026013 - Urethral Catheter Electrode: 2021-06-01