FDA UDI
In Commercial Distribution
🇺🇸 United States
DuoMAG NL
DI: 08592566001055
·
Model: DM-NL
·
DEYMED Diagnostic s.r.o.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- DuoMAG NL
- Primary DI
- 08592566001055
- Version / Model
- DM-NL
- Catalog Number
- DM-NL
- Company Name
- DEYMED Diagnostic s.r.o.
- Labeler DUNS
- 495566056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-29
- Public Version
- 3
- Public Version Date
- 2024-02-26
- Public Version Status
- Update
- Public Device Record Key
- 4b0bc2ab-fdbd-4898-864d-9d339342e05d
Device Description
The DuoMAG NL is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain. DuoMAG NL consists of a Magnetic stimulator DuoMAG XT-NL, stimulation coil, trolley MagCart, and LiquidCool System unit.
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 |
|---|---|---|---|---|
| QPL | Electromagnetic Stimulator, Pain Relief | Neurology | 882.5890 | 2 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61124 | Magnetic neural stimulation system | An assembly of electrically-powered devices intended for the treatment and/or diagnosis 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08592566001055 | GS1 |
Customer Contacts
- Phone
- +1 858 229 9218
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 45 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 107 KiloPascal