FDA UDI
In Commercial Distribution
🇺🇸 United States
STM9000 ULTRA-FAST_BI
DI: 08056446900871
·
Model: B9700086170
·
EB NEURO SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STM9000 ULTRA-FAST_BI
- Primary DI
- 08056446900871
- Version / Model
- B9700086170
- Company Name
- EB NEURO SPA
- Labeler DUNS
- 339182263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-24
- Public Version
- 1
- Public Version Date
- 2019-06-03
- Public Version Status
- New
- Public Device Record Key
- a4971a0c-79c9-4ccf-8cdd-ff0ff73cda4d
Device Description
Magnetic neural stimulation equipment. (Power supply voltage: 230VAC).
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 |
|---|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61160 | Magnetic neural stimulation system, stationary | A stationary assembly of mains electricity (AC-powered) devices intended for the treatment of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools to enhance the therapeutic effect. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056446900871 | GS1 |
Customer Contacts
- Phone
- +390554565111
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150220 | 000 |