FDA.reportPublic FDA data

Single Use Electrodes Sterile - 6 pcs

Primary DI
07350094440200
Brand
Single Use Electrodes Sterile - 6 pcs
Company
Scibase AB
Model
131-0007
Catalog number
131-0007
Device description
Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 times for a single patient on several lesions in a single procedure.
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
07350094440200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350094440200073500944402007350094440200

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
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
07350094440101Test Impedance ToolScibase ABONV2017-11-21
07350094440194Control Unit BatteryScibase ABONV2017-11-21
07350094440217Training electrode Sterile - 6 pcsScibase ABONV2017-11-21