DEVICE: BodyFIX (04056719000080)
Device Identifier (DI) Information
BodyFIX
P10102-150
In Commercial Distribution
P10102-150
Medical Intelligence Medizintechnik GmbH
P10102-150
In Commercial Distribution
P10102-150
Medical Intelligence Medizintechnik GmbH
BodyFix® Vacuum Pump P3 is a vacuum pump that controls the dual-vacuum technology, used for precise patient positioning and immobilization of the BodyFIX® System.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Vacuum-mould patient positioning system | An assembly of devices designed to apply a vacuum to a cushion or bag filled with foam-like material that is placed under, on, or around a patients body parts. A vacuum is applied to the contents of the cushion forming a patient specific (custom-made) mould. The moulds can be whole body or selected body parts and help ensure adequate positioning and immobilization of the patient during diagnostic imaging and/or radiation therapy procedures facilitating reproducible positioning for serial procedures. This system typically includes reusable foam-filled bags, cushions, a vacuum unit, hardware, seals, and interfaces used to connect the mould to another patient positioning system (PPS). |
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
010d10e3-8ae7-4808-be0e-a93c948a9e60
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined