PointerShell 5mm
EUDAMEDFDA UDIClass I (EU MDR)
by Fiagon GmbH
Identity
- Trade Name
- PointerShell 5mm EUDAMEDPointerShell 5 mm FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. The device is accessory to the Cube 4D Navigation system. FDA UDI
- Model / Reference
- Accessory to Cube4D Navigation System / Instrument tracker EUDAMEDE 01 2901 EUDAMEDE012901 FDA UDI
- Description
- The device PointerShell 5mm is an instrument tracker adapter for image guided surgery for instruments shafts of 4.7mm to 5mm. The device is accessory to the Cube 4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E012901 FDA UDI
- Primary DI / UDI-DI
- 04260759930379 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E0056H EUDAMED
- Direct Marketing DI
- 04260759930379 EUDAMED
- 510(k) Number
- K141456 FDA UDI
- FDA Product Code
- PGW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Neurological stereotactic surgery system
PointerShell 5mm by Fiagon GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426075993E0056H | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
- EUDAMED SRN
- DE-MF-000010763
Sources (2)
- EUDAMED 32dee087-d075-48fe-86b0-d9e45c366cfd 61 fields · synced May 30, 2026
- FDA UDI 5f565595-ee14-4601-adf3-63be14384b65 36 fields · synced May 30, 2026