FDA UDI
In Commercial Distribution
🇺🇸 United States
MagPro Accessories
DI: 05713484031303
·
Model: Flow Am coil adapter kit, ø29-2pcs
·
Tonica Elektronik A/S
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MagPro Accessories
- Primary DI
- 05713484031303
- Version / Model
- Flow Am coil adapter kit, ø29-2pcs
- Catalog Number
- 9016B0841
- Company Name
- Tonica Elektronik A/S
- Labeler DUNS
- 566622973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-28
- Public Version
- 1
- Public Version Date
- 2022-12-06
- Public Version Status
- New
- Public Device Record Key
- 2232347c-4244-46f5-b8f5-903b04cf56d3
Device Description
Flow Am coil adapter kit, ø29-2pcs. Approved with Flow Arm (9016B0801).
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | Neurology | 882.5802 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 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 | 05713484031303 | GS1 |
Customer Contacts
- Phone
- 8886247764
- [email protected]