FDA UDI
In Commercial Distribution
🇺🇸 United States
NExT Station
DI: 08056446901205
·
Model: B9800096001
·
EB NEURO SPA
Product Codes
6
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NExT Station
- Primary DI
- 08056446901205
- Version / Model
- B9800096001
- Company Name
- EB NEURO SPA
- Labeler DUNS
- 339182263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-22
- Public Version
- 1
- Public Version Date
- 2025-05-30
- Public Version Status
- New
- Public Device Record Key
- d5838c7b-8104-43d4-aefd-d7df25bf0b53
Device Description
EMG/EP Amplifier with accessories
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
- Yes
- 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 |
|---|---|---|---|---|
| GWL | Amplifier, Physiological Signal | Neurology | 882.1835 | 2 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | Neurology | 882.1400 | 2 |
| IKN | Electromyograph, Diagnostic | Physical Medicine | 890.1375 | 2 |
| GWE | Stimulator, Photic, Evoked Response | Neurology | 882.1890 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11474 | Electromyograph | An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer. | No | Active |
| 11614 | Evoked-potential graphic recording system | An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056446901205 | GS1 |
Customer Contacts
- Phone
- +390554565111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242832 | 000 |