Test Impedance Tool

Primary DI
07350094440101
Brand
Test Impedance Tool
Company
Scibase AB
Model
590-0002
Catalog number
590-0002
Device description
The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measurement accuracy test should be performed once a month, to ensure that all Nevisense examinations will present correct measurement data.
Published
2017-11-21
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
CodeName
ONVElectrical Impedance Spectrometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONVElectrical Impedance SpectrometerGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150046000NEVISENSEScibase AB2017-06-28ONV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350094440101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350094440101073500944401017350094440101

GMDN Terms#

Term, Definition table
TermDefinition
Neoplasm electrical impedance spectrometerA mains electricity (AC-powered) instrument intended to measure/map the differences in capacitance and resistance between neoplastic and surrounding normal tissue, using electrical impedance spectroscopy (EIS). It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement and/or imaging of local distributions of tissue electrical impedance by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. It is intended to indicate cytological and histological tissue changes typically in combination with other methodologies (e.g., mammography, visual examination).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
776863743
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350094440071Nevisense511-0001511-00012017-11-21
07350094440088Probe unit512-0003512-00032017-11-21
07350094440095Probe cable730-0009730-00092017-11-21
07350094440194Control Unit Battery521-0001521-00012017-11-21
07350094440200Single Use Electrodes Sterile - 6 pcs131-0007131-00072017-11-21
07350094440217Training electrode Sterile - 6 pcs131-0008131-00082017-11-21
07350094440279NeviFile kit US142-0013142-00132019-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350094440279NeviFile kit USScibase ABONV2019-01-30
07350094440071NevisenseScibase ABONV2017-11-21
07350094440088Probe unitScibase ABONV2017-11-21
07350094440095Probe cableScibase ABONV2017-11-21
07350094440194Control Unit BatteryScibase ABONV2017-11-21
07350094440200Single Use Electrodes Sterile - 6 pcsScibase ABONV2017-11-21
07350094440217Training electrode Sterile - 6 pcsScibase ABONV2017-11-21