FDA UDI
In Commercial Distribution
🇺🇸 United States
Training electrode Sterile - 6 pcs
DI: 07350094440217
·
Model: 131-0008
·
Scibase AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Training electrode Sterile - 6 pcs
- Primary DI
- 07350094440217
- Version / Model
- 131-0008
- Catalog Number
- 131-0008
- 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
- 500ea5f4-6efe-484f-9b0e-902b6e067fb0
Device 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.
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 | 07350094440217 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150046 | 000 |