| Primary Device ID | 07350094440095 |
| NIH Device Record Key | b845ec06-19da-446c-90f3-01106f484737 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Probe cable |
| Version Model Number | 730-0009 |
| Catalog Number | 730-0009 |
| Company DUNS | 776863743 |
| Company Name | Scibase AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350094440095 [Primary] |
| ONV | Electrical Impedance Spectrometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-21 |
| 07350094440279 - NeviFile kit US | 2019-03-04 NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is use |
| 07350094440071 - Nevisense | 2018-07-06 Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS |
| 07350094440088 - Probe unit | 2018-07-06 Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe. |
| 07350094440095 - Probe cable | 2018-07-06Cable used for connection of Probe unit with Nevisense. |
| 07350094440095 - Probe cable | 2018-07-06 Cable used for connection of Probe unit with Nevisense. |
| 07350094440101 - Test Impedance Tool | 2018-07-06 The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measure |
| 07350094440194 - Control Unit Battery | 2018-07-06 Battery used in addition to the power cord for the Nevisense to enable use of the Nevisense as a portable device. |
| 07350094440200 - Single Use Electrodes Sterile - 6 pcs | 2018-07-06 Examination electrodes, used when performing measurements with the Nevisense on patients. Each electrode can be used up to 20 ti |
| 07350094440217 - Training electrode Sterile - 6 pcs | 2018-07-06 Training electrodes, used for Nevisense training and qualification. Each electrode is to be used only on intact, healthy skin on |