Training electrode Sterile - 6 pcs

Primary DI
07350094440217
Brand
Training electrode Sterile - 6 pcs
Company
Scibase AB
Model
131-0008
Catalog number
131-0008
Device description
Training electrodes, used for Nevisense training and qualification. Each electrode is to be used only on intact, healthy skin on a single person in a single training session. Each electrode can be used up to 50 times. The reason for the higher number (i.e., 50, as compared with 20 for the examination electrode) is that these electrodes are used for training and qualification purposes only.
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
07350094440217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350094440217073500944402177350094440217

GMDN Terms#

Term, Definition table
TermDefinition
Neoplasm electrical impedance spectrometer electrode arrayA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
776863743
Device count
1
Lot or batch
true
Expiration date on label
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
07350094440101Test Impedance Tool590-0002590-00022017-11-21
07350094440194Control Unit Battery521-0001521-00012017-11-21
07350094440200Single Use Electrodes Sterile - 6 pcs131-0007131-00072017-11-21
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
07350094440101Test Impedance ToolScibase ABONV2017-11-21
07350094440194Control Unit BatteryScibase ABONV2017-11-21
07350094440200Single Use Electrodes Sterile - 6 pcsScibase ABONV2017-11-21