SafePrep

GUDID 08054655031843

SPES MEDICA SRL

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium

• Primary Device ID: 08054655031843
• NIH Device Record Key: a3c0b547-07c8-402e-b4a8-209efdc7b255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafePrep
• Version Model Number: NPREP010E-1
• Company DUNS: 514029771
• Company Name: SPES MEDICA SRL
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	08054655031843 [Unit of Use]
GS1	18054655031840 [Primary]

FDA Product Code

• KOY: Degreaser, Skin, Surgical

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: 2021-08-13
• Device Publish Date: 2021-08-05

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
• 08054655031843 - SafePrep: 2021-08-13
• 18054655025979 - Urethral Catheter Electrode: 2021-06-01
• 18054655026013 - Urethral Catheter Electrode: 2021-06-01