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 Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer Neoplasm electrical impedance spectrometer 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