DEVICE: BodyFIX (04056719000103)
Device Identifier (DI) Information
BodyFIX
P10102-201
In Commercial Distribution
P10102-201
3C-Medical Intelligence GmbH
P10102-201
In Commercial Distribution
P10102-201
3C-Medical Intelligence GmbH
BodyFIX® Manifold Cushion 700mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
40895 | 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).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IYE | Accelerator, Linear, Medical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121530 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1e89f374-c6db-4335-a54c-4b395de9318d
December 15, 2023
5
August 23, 2016
December 15, 2023
5
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 |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
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