DEVICE: Fraxion (04056719001377)
Device Identifier (DI) Information
Fraxion
P10106-102
In Commercial Distribution
P10106-102
3C-Medical Intelligence GmbH
P10106-102
In Commercial Distribution
P10106-102
3C-Medical Intelligence GmbH
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61128 | Stereotactic radiosurgical/radiotherapy arch head frame |
A non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and neck. It is in the form of an arched frame to which can be attached various components (e.g., mouthpiece, nasion cushion) that non-invasively contact the patient to serve as points of reference, and which is typically attached to a base plate, couch top, or overlay. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IYE | Accelerator, Linear, Medical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cce8c39b-38b6-4bd2-aa8c-9a07ba0c7984
December 15, 2023
6
August 23, 2016
December 15, 2023
6
August 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined