Identity
- Trade Name
- MagPro Accessories FDA UDI
- Generic Name
- Magnetic neural stimulation system FDA UDI
- Device Name
- cable splitter for external triggering af a MagPro slave device as well as an external device. Approved with MagPro R30 in K061645. FDA UDI
- Model / Reference
- Cable Splitter Ext. Trig for MagPro slave and Keypoint FDA UDI
- Description
- cable splitter for external triggering af a MagPro slave device as well as an external device. Approved with MagPro R30 in K061645. FDA UDI
Identifiers
- Catalog Number
- 9016E4581 FDA UDI
- Primary DI / UDI-DI
- 05713484030726 FDA UDI
- 510(k) Number
- K061645 FDA UDI
- FDA Product Code
- GWF FDA UDI
- GMDN Term
- Magnetic neural stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Magnetic neural stimulation system
MagPro Accessories by Tonica Elektronik A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Magnetic neural stimulation system.
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Cleared under the same submission
K061645 also covers:
- MagPro — Tonica Elektronik A/S
- MagPro — Tonica Elektronik A/S
- MagPro — Tonica Elektronik A/S
- MagPro — Tonica Elektronik A/S
- MagPro — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
- MagPro Accessories — Tonica Elektronik A/S
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tonica Elektronik A/S
Sources (1)
- FDA UDI 530f4dfa-7674-4182-9f91-0a72a57dc592 36 fields · synced May 30, 2026