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Fraxion Mouthpiece Small P2
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10106-328Ref P10106-325
Identity
- Trade Name
- Fraxion Mouthpiece Small P2 EUDAMEDFraxion Mouthpiece Small EUDAMEDFraxion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- Fraxion EUDAMEDThe FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. FDA UDIThe FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. FDA UDI
- Model / Reference
- P10106-328 EUDAMEDP10106-325 EUDAMEDP10106-320 FDA UDIP10106-323 FDA UDI
- Description
- The FRAXION™ Mouthpiece is affixed to the Fraxion Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. FDA UDIThe FRAXION™ Mouthpiece is affixed to the FRAXION™ Frontpiece assuring safe immobilization and precise (re-) positioning. The mouthpiece is also fixed to the patient’s maxilla with a vacuum. FDA UDI
Identifiers
- Catalog Number
- P10106-320 FDA UDIP10106-323 FDA UDI
- Primary DI / UDI-DI
- 04056719001780 EUDAMEDFDA UDI04056719001759 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000002HW EUDAMED
- 510(k) Number
- K112210 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Fraxion Mouthpiece Small P2 by 3C-Medical Intelligence 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 | 04056719BUDI0000000002HW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
- EUDAMED SRN
- DE-MF-000023763
Sources (5)
- EUDAMED e899f4da-6a36-46e8-9f8b-b56088f7abdd 61 fields · synced Jul 21, 2026
- EUDAMED a6aa3e9a-3ce9-4666-9fd7-65ae247059f4 61 fields · synced May 18, 2026
- FDA UDI 0b36f5fb-f598-4bf2-b504-77fc807f1502 35 fields · synced May 29, 2026
- FDA UDI f357f20d-d013-47bd-ad66-c468ee721336 35 fields · synced May 30, 2026
- EUDAMED 7d294550-40cf-4763-8771-ef820dc1e476 61 fields · synced Jul 21, 2026