Identity
- Trade Name
- PointerShell 4 mm FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ‘PointerShells’ below. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The product PointerShell 4 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ‘PointerShells’ below. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- EFIAE0129001 FDA UDI
- 510(k) Number
- K141456 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
PointerShell 4 mm by Fiagon GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 2a9b0d70-629f-4b17-84c1-790e0acb6478 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026