NeviFile kit US 142-0013

GUDID 07350094440279

NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is used for printing reports

Scibase AB

Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array Neoplasm electrical impedance spectrometer electrode array
Primary Device ID07350094440279
NIH Device Record Key39c4780e-04bf-41a8-889b-6e960770c6d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeviFile kit US
Version Model Number142-0013
Catalog Number142-0013
Company DUNS776863743
Company NameScibase AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350094440279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONVElectrical Impedance Spectrometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-04
Device Publish Date2019-01-30

Devices Manufactured by Scibase AB

07350094440279 - NeviFile kit US2019-03-04NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is used for printing reports
07350094440279 - NeviFile kit US2019-03-04 NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is use
07350094440071 - Nevisense2018-07-06 Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS
07350094440088 - Probe unit2018-07-06 Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe.
07350094440095 - Probe cable2018-07-06 Cable used for connection of Probe unit with Nevisense.
07350094440101 - Test Impedance Tool2018-07-06 The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measure
07350094440194 - Control Unit Battery2018-07-06 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 pcs2018-07-06 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 pcs2018-07-06 Training electrodes, used for Nevisense training and qualification. Each electrode is to be used only on intact, healthy skin on

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