Identity
- Trade Name
- HexaPOD Handheld Controller EUDAMEDHexaPOD FDA UDI
- Generic Name
- Accelerator system table, powered FDA UDI
- Device Name
- HexaPOD evo RT System EUDAMEDHexaPOD Handheld Controller for manual movement of HexaPOD evo module FDA UDI
- Model / Reference
- P10602-107 EUDAMEDFDA UDI
- Description
- HexaPOD Handheld Controller for manual movement of HexaPOD evo module FDA UDI
Identifiers
- Catalog Number
- P10602-107 FDA UDI
- Primary DI / UDI-DI
- 04056719001667 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000005J4 EUDAMED
- Direct Marketing DI
- 04056719001667 EUDAMED
- 510(k) Number
- K072898 FDA UDI
- FDA Product Code
- JAI FDA UDI
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
- GMDN Term
- Accelerator system table, powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5770 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Accelerator system table, powered
HexaPOD by 3C-Medical Intelligence GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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
- 3C-Medical Intelligence GmbH
Sources (2)
- FDA UDI 71cacd3c-eaa1-4438-82c2-68970c88769d 35 fields · synced Jul 19, 2026
- EUDAMED 9457e90d-2596-4c35-8934-35576b59acba 61 fields · synced Jul 19, 2026