DEVICE: Fraxion (04056719001513)
Device Identifier (DI) Information
Fraxion
P10106-200
In Commercial Distribution
P10106-200
Medical Intelligence Medizintechnik GmbH
P10106-200
In Commercial Distribution
P10106-200
Medical Intelligence Medizintechnik GmbH
The FRAXION™ Marking Sheets are used togethter with the FRAXION™ Stereotactic Frame in order to locate the treatment target in the coordinate system and position the patient. The marking sheets will be stored together with all patient-specific parts in the storage box for the whole treatment time.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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
d358ea0d-3094-4c37-8aaf-ebb189d609fb
March 29, 2018
2
August 23, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04056719001988
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined