Nevisense 511-0001

GUDID 07350094440071

Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score. Electrical i

Scibase AB

Neoplasm electrical impedance spectrometer

• Primary Device ID: 07350094440071
• NIH Device Record Key: d276066d-54d5-4a51-a1fa-6f046b524b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nevisense
• Version Model Number: 511-0001
• Catalog Number: 511-0001
• Company DUNS: 776863743
• Company Name: Scibase AB
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350094440071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150046

FDA Product Code

• ONV: Electrical Impedance Spectrometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-21

Devices Manufactured by Scibase AB

• 07350094440279 - NeviFile kit US: 2019-03-04 NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is use
• 07350094440071 - Nevisense: 2018-07-06Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score. Electrical i
• 07350094440071 - Nevisense: 2018-07-06 Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS
• 07350094440088 - Probe unit: 2018-07-06 Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe.
• 07350094440095 - Probe cable: 2018-07-06 Cable used for connection of Probe unit with Nevisense.
• 07350094440101 - Test Impedance Tool: 2018-07-06 The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measure
• 07350094440194 - Control Unit Battery: 2018-07-06 Battery used in addition to the power cord for the Nevisense to enable use of the Nevisense as a portable device.
• 07350094440200 - Single Use Electrodes Sterile - 6 pcs: 2018-07-06 Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 ti
• 07350094440217 - Training electrode Sterile - 6 pcs: 2018-07-06 Training electrodes, used for Nevisense training and qualification. Each electrode is to be used only on intact, healthy skin on