FDA UDI
In Commercial Distribution
🇺🇸 United States
HORIZON™ Air Film Coil
DI: 05060229532268
·
Model: 4980-00
·
THE MAGSTIM COMPANY LIMITED
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HORIZON™ Air Film Coil
- Primary DI
- 05060229532268
- Version / Model
- 4980-00
- Company Name
- THE MAGSTIM COMPANY LIMITED
- Labeler DUNS
- 500375274
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-22
- Public Version
- 6
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- f9f5c73f-ca2d-4450-a6ad-caa8377f5cc1
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 |
|---|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | Neurology | 882.5805 | 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 |
| 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 | 05060229532268 | GS1 |
Customer Contacts
- Phone
- +441994240798
- [email protected]
- Phone
- +441994241111
- [email protected]