Identity
- Trade Name
- SAINT FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Model / Reference
- Magnus Neuromodulation Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011072515 FDA UDI
- 510(k) Number
- K220177 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
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
No
FDA UDI
Category: Stereotactic neuronavigation/planning system
Saint by Magnus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- tracking tools — eemagine Medical Imaging Solutions GmbH · Class II
- tracking tools — eemagine Medical Imaging Solutions GmbH · Class II
- tracking tools — eemagine Medical Imaging Solutions GmbH · Class II
- Localite TMS Navigator TS — LOCALITE GmbH · Class II
Cleared under the same submission
K220177 also covers:
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
- Magnus Medical, Inc.
Sources (1)
- FDA UDI 043740da-ab6e-40d0-979e-02e69bcf60bc 34 fields · synced May 31, 2026