Identity
- Trade Name
- Localite TMS Navigator TS FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Model / Reference
- Functional Data (Software Module) FDA UDI
Identifiers
- Catalog Number
- 10233 FDA UDI
- Primary DI / UDI-DI
- G076A010233AM3N40 FDA UDI
- 510(k) Number
- K223577 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stereotactic neuronavigation/planning system
Localite TMS Navigator TS by LOCALITE GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223577 also covers:
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
- Localite TMS Navigator TS — LOCALITE GmbH
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
- LOCALITE GmbH
Sources (1)
- FDA UDI 8b32c377-32f2-4266-8e50-d8d3ee0fa78f 34 fields · synced Jun 8, 2026