Identity
- Trade Name
- Localizer Headband FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The product Localizer Headband is a product variant of a patient reference localisator. for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid laws and regulations. An operator is everyone who uses the system. The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The product Localizer Headband is a product variant of a patient reference localisator. for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid laws and regulations. An operator is everyone who uses the system. The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFIAE0122001 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.035 Kilogram FDA UDIHeight — 15 Millimeter FDA UDIWidth — 30 Millimeter FDA UDILength — 45 Millimeter FDA UDI
Localizer Headband by Fiagon GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Fiagon GmbH
Sources (1)
- FDA UDI eea92179-a8dc-4508-a51a-7337e8d5b3b6 37 fields · synced May 30, 2026