FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Electrodes Sterile - 6 pcs
DI: 07350094440200
·
Model: 131-0007
·
Scibase AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Single Use Electrodes Sterile - 6 pcs
- Primary DI
- 07350094440200
- Version / Model
- 131-0007
- Catalog Number
- 131-0007
- 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
- 7c0384ee-1158-4bd2-a0f4-89bf9e2d67c7
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.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 60474 | Neoplasm electrical impedance spectrometer electrode array | An arrangement of multiple electrical conductors intended to be used in conjunction with an electrical impedance (bioimpedance) spectrometer (EIS/BIS) to apply a small electric current to the skin during EIS analysis, typically 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350094440200 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150046 | 000 |