Identity
- Trade Name
- Fraxion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- "The Fraxion FRAXION™ Kit includes all necessary components to generate a patient-specific mouthpiece. It contains also the necessary Saliva Stop Patient which prevents saliva from reaching the Patient Control Unit (sufficient for up to 20 patients)." FDA UDI
- Model / Reference
- P10106-602 FDA UDI
- Description
- "The Fraxion FRAXION™ Kit includes all necessary components to generate a patient-specific mouthpiece. It contains also the necessary Saliva Stop Patient which prevents saliva from reaching the Patient Control Unit (sufficient for up to 20 patients)." FDA UDI
Identifiers
- Catalog Number
- P10106-602 FDA UDI
- Primary DI / UDI-DI
- 04056719001643 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Stereotactic radiosurgical/radiotherapy arch head frame
Fraxion by 3C-Medical Intelligence GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stereotactic radiosurgical/radiotherapy arch head frame.
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- ShoulderAssist, PositionPro — Aktina Corp. · Class II
- PinPoint Arch Support, Extended — Aktina Corp. · Class II
- PinPoint Radiosurgery Immobilization System, Elekta Compatible — Aktina Corp. · Class II
- Carbon Fiber Board, Short — Aktina Corp. · Class II
- PinPoint Mouthpiece Assembly, Medium — Aktina Corp. · Class II
- PositionPro Head Cradle — Aktina Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
Sources (1)
- FDA UDI 6ef06168-781c-405e-9cd9-96a669ca973c 34 fields · synced Jun 8, 2026