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Fraxion Thermoplastic Mask Single Layer (10 PCS)
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10106-302
Identity
- Trade Name
- Fraxion Thermoplastic Mask Single Layer (10 PCS) EUDAMEDFraxion™ FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- Fraxion EUDAMEDThe Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer. FDA UDI
- Model / Reference
- P10106-302 EUDAMEDFDA UDI
- Description
- The Fraxion™ Thermoplastic Mask Single Layer (10pcs) is affixed to the Fraxion Headrest assuring safe immobilization and precise (re-) positioning. It is used in combination with the Fraxion Vacuum Cushion or Fraxion Vacuum Cushion Plus and the Fraxion Spacer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056719002084 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000002HW EUDAMED
- Unit of Use DI
- 04056719002183 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fraxion Thermoplastic Mask Single Layer (10 PCS) by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 (2)
- EUDAMED 765e0c61-9338-4d3c-8e94-3f968eea7dae 61 fields · synced Jun 17, 2026
- FDA UDI cefbeda1-f92a-49d6-a5d8-30f539457105 35 fields · synced May 30, 2026