Identity
- Trade Name
- Fraxion FDA UDI
- Generic Name
- Stereotactic radiosurgical/radiotherapy arch head frame FDA UDI
- Device Name
- The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securing the mouthpiece to the patient’s maxilla, thus securely immobilizing the patient. It monitors the vacuum level to the mouthpiece and provides an alert when the mouthpiece becomes loosened. Additionally, the PCU is used for forming the vacuum cushion. FDA UDI
- Model / Reference
- P10106-102 FDA UDI
- Description
- The FRAXION™ Patient Control Unit (PCU) provides the vacuum necessary for securing the mouthpiece to the patient’s maxilla, thus securely immobilizing the patient. It monitors the vacuum level to the mouthpiece and provides an alert when the mouthpiece becomes loosened. Additionally, the PCU is used for forming the vacuum cushion. FDA UDI
Identifiers
- Catalog Number
- P10106-102 FDA UDI
- Primary DI / UDI-DI
- 04056719001377 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
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.
- Arch Kit, PositionPro — Aktina Corp. · Class II
- Nasion Cushion — Medtec LLC · Class II
- 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 cce8c39b-38b6-4bd2-aa8c-9a07ba0c7984 34 fields · synced May 30, 2026