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Training electrode Sterile - 6 pcs

FDA UDI

Class II (US FDA UDI)

by Scibase AB

Identity

Trade Name
Training electrode Sterile - 6 pcs FDA UDI
Generic Name
Neoplasm electrical impedance spectrometer electrode array FDA UDI
Device Name
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. FDA UDI
Model / Reference
131-0008 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
131-0008 FDA UDI
Primary DI / UDI-DI
07350094440217 FDA UDI
PMA Number
P150046 FDA UDI
FDA Product Code
ONV FDA UDI
GMDN Term
Neoplasm electrical impedance spectrometer electrode array FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.1820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Neoplasm electrical impedance spectrometer electrode array

Training electrode Sterile - 6 pcs by Scibase AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neoplasm electrical impedance spectrometer electrode array.

Cleared under the same submission

P150046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scibase AB

Sources (1)

  • FDA UDI 500ea5f4-6efe-484f-9b0e-902b6e067fb0 35 fields · synced Jun 1, 2026