FDA UDI
In Commercial Distribution
🇺🇸 United States
RST-SANEXAS Basic
DI: 00860000214032
·
Model: RST-SANEXAS Basic
·
Rst- Sanexas
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RST-SANEXAS Basic
- Primary DI
- 00860000214032
- Version / Model
- RST-SANEXAS Basic
- Company Name
- Rst- Sanexas
- Labeler DUNS
- 109562944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-16
- Public Version
- 2
- Public Version Date
- 2022-08-15
- Public Version Status
- Update
- Public Device Record Key
- 049edc10-736d-474d-878c-c2ff6912d58a
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
- No
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| LIH | Interferential Current Therapy | Neurology | 882.5890 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31268 | Transcranial electrical stimulation system, pulsed-current | A noninvasive assembly of mains electricity (AC-powered) devices designed to apply weak, pulsed (not continuous) electrical stimuli to a patient's brain to treat one or more psychiatric disorders which may include anxiety, depression, insomnia, and/or addiction; it may also be intended to induce a state resembling that of chemically-induced anaesthesia. It usually includes an electrical pulse generator with controls to vary the pulse rate, pulse width, and voltage or current, with the current applied via leads and appropriate scalp electrodes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860000214032 | GS1 |
Customer Contacts
- Phone
- 866-726-3927
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022433 | 000 |