FDA UDI
In Commercial Distribution
🇺🇸 United States
Probe unit
DI: 07350094440088
·
Model: 512-0003
·
Scibase AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Probe unit
- Primary DI
- 07350094440088
- Version / Model
- 512-0003
- Catalog Number
- 512-0003
- Company Name
- Scibase AB
- Labeler DUNS
- 776863743
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-21
- Public Version
- 6
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 06bf45e1-e5f2-4405-9adb-35ac0ad8f72f
Device Description
Used with the Nevisense to perform lesion examinations on patients, using disposable electrodes attached to the probe.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONV | Electrical Impedance Spectrometer | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42183 | Neoplasm electrical impedance spectrometer | An electrically-powered instrument intended to measure/map the differences in capacitance and resistance between neoplastic and surrounding normal tissue, using electrical impedance (bioimpedance) spectroscopy (EIS/BIS). 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 typically used for the detection of neoplastic skin and breast cancer, typically in combination with other methodologies (e.g., mammography, visual examination). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350094440088 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150046 | 000 |