Identity
- Trade Name
- Control Unit Battery FDA UDI
- Generic Name
- Neoplasm electrical impedance spectrometer FDA UDI
- Device Name
- Battery used in addition to the power cord for the Nevisense to enable use of the Nevisense as a portable device. FDA UDI
- Model / Reference
- 521-0001 FDA UDI
- Description
- Battery used in addition to the power cord for the Nevisense to enable use of the Nevisense as a portable device. FDA UDI
Identifiers
- Catalog Number
- 521-0001 FDA UDI
- Primary DI / UDI-DI
- 07350094440194 FDA UDI
- PMA Number
- P150046 FDA UDI
- FDA Product Code
- ONV FDA UDI
- GMDN Term
- Neoplasm electrical impedance spectrometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.1820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neoplasm electrical impedance spectrometer
Control Unit Battery by Scibase AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neoplasm electrical impedance spectrometer.
- Test Impedance Tool — Scibase AB · Class II
- Probe cable — Scibase AB · Class II
- Nevisense — Scibase AB · Class II
- Probe unit — Scibase AB · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scibase AB
Sources (1)
- FDA UDI 9c2b8358-c0d7-4c52-bab7-079bc3e8af29 35 fields · synced May 30, 2026