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Localizer Adhesive pad Cranial
FDA UDIEUDAMEDClass II (US FDA UDI)
by Fiagon GmbH
Identity
- Trade Name
- Localizer Adhesive pad Cranial FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The product Localizer Adhesive pad Cranial is a product variant of a patient reference localisator for image guided surgical procedures. The adhesive pad is an accessory of the Localizer Adhesive Pad. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The product Localizer Adhesive pad Cranial is a product variant of a patient reference localisator for image guided surgical procedures. The adhesive pad is an accessory of the Localizer Adhesive Pad. FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFIAE012202CUS1 FDA UDI
- FDA Product Code
- HAW 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
Localizer Adhesive pad Cranial by Fiagon GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K151156 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (2)
- FDA UDI 29a64600-9d2c-432d-bd5f-114101aa55fe 37 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 5, 2026