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PointerShell 3mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref E 01 2902Model Accessory to Cube4D Navigation System / Instrument tracker
by Fiagon GmbH
Identity
- Trade Name
- PointerShell 3mm EUDAMEDPointerShell 3 mm FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm. The device is accessory to the Cube 4D Navigation system. FDA UDI
- Model / Reference
- Accessory to Cube4D Navigation System / Instrument tracker EUDAMEDE 01 2902 EUDAMEDE012902 FDA UDI
- Description
- The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm. The device is accessory to the Cube 4D Navigation system. FDA UDI
Identifiers
- Catalog Number
- E012902 FDA UDI
- Primary DI / UDI-DI
- 04260759930386 EUDAMEDFDA UDI
- Basic UDI-DI
- 426075993E0056H EUDAMED
- Direct Marketing DI
- 04260759930386 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 3mm by Fiagon GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 003c5beb-b5db-4750-9495-e4f17543618e 61 fields · synced Jun 18, 2026
- FDA UDI f75f8f76-5c88-4575-b0a1-cb4c747e22a5 36 fields · synced May 29, 2026