NeviFile kit US

Primary DI: 07350094440279
Brand: NeviFile kit US
Company: Scibase AB
Model: 142-0013
Catalog number: 142-0013
Device description: 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 as well as saving reports for viewing. NeviFile is also needed to be able to print reports from Nevisense via network, immediately when an examination iscompleted and a report is created.
Published: 2019-01-30
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Product Codes#

Code, Name table
Code	Name
ONV	Electrical Impedance Spectrometer

Code, Device, Specialty table
Code	Device	Specialty	Class
ONV	Electrical Impedance Spectrometer	General, Plastic Surgery	2

Submission, Supplement table
Submission	Supplement
P150046	002

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
P150046	002	NEVISENSE	Scibase AB	2017-06-28	ONV

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
07350094440279	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
07350094440279	07350094440279	7350094440279

Term, Definition table
Term	Definition
Neoplasm electrical impedance spectrometer electrode array	A non-sterile arrangement of multiple electrical conductors intended to be used in conjunction with an electrical impedance spectrometer (EIS) to apply a small electric current to the skin during EIS analysis of neoplastic skin. It is typically a small cover that fits over a probe and may be textured (e.g., with pins) to penetrate the outermost layer of skin. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Method table
Method

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
07350094440071	Nevisense	511-0001	511-0001	2017-11-21
07350094440088	Probe unit	512-0003	512-0003	2017-11-21
07350094440095	Probe cable	730-0009	730-0009	2017-11-21
07350094440101	Test Impedance Tool	590-0002	590-0002	2017-11-21
07350094440194	Control Unit Battery	521-0001	521-0001	2017-11-21
07350094440200	Single Use Electrodes Sterile - 6 pcs	131-0007	131-0007	2017-11-21
07350094440217	Training electrode Sterile - 6 pcs	131-0008	131-0008	2017-11-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07350094440071	Nevisense	Scibase AB	ONV	2017-11-21
07350094440088	Probe unit	Scibase AB	ONV	2017-11-21
07350094440095	Probe cable	Scibase AB	ONV	2017-11-21
07350094440101	Test Impedance Tool	Scibase AB	ONV	2017-11-21
07350094440194	Control Unit Battery	Scibase AB	ONV	2017-11-21
07350094440200	Single Use Electrodes Sterile - 6 pcs	Scibase AB	ONV	2017-11-21
07350094440217	Training electrode Sterile - 6 pcs	Scibase AB	ONV	2017-11-21