FDA UDI
In Commercial Distribution
🇺🇸 United States
Test Impedance Tool
DI: 07350094440101
·
Model: 590-0002
·
Scibase AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Test Impedance Tool
- Primary DI
- 07350094440101
- Version / Model
- 590-0002
- Catalog Number
- 590-0002
- 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
- 7
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- 954f440d-4a9b-457a-9d18-fcbf69d550b2
Device Description
The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measurement accuracy test should be performed once a month, to ensure that all Nevisense examinations will present correct measurement data.
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 | General, Plastic Surgery | 878.1820 | 2 |
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 provides real-time, noninvasive, radiation-free measurement and/or imaging of local distributions of tissue electrical impedance by applying and detecting a low-voltage electrical signal through the skin, via cutaneous electrodes, and displaying the results on a built-in or external screen (e.g., monitor, tablet). It is 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 | 07350094440101 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150046 | 000 |