Identity
- Trade Name
- Neuro-IOM FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist. FDA UDI
- Model / Reference
- Neuro-IOM FDA UDI
- Description
- Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04650075330371 FDA UDI
- 510(k) Number
- K190703 FDA UDI
- FDA Product Code
- GWF FDA UDIGWE FDA UDIGWJ FDA UDIOLT FDA UDIPDQ FDA UDI
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.1890 FDA UDI882.1900 FDA UDI882.1400 FDA UDI874.1820 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
Yes
FDA UDI
Category: Neurophysiologic monitoring system
Neuro-IOM by Neurosoft, Ooo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Neurosoft, Ooo
Sources (1)
- FDA UDI a256d837-17f7-4ce4-abcc-dbd397246e01 35 fields · synced May 29, 2026