DEVICE: Proton Systems, LLC (00861206000344)

Download: XML | JSON

Device Identifier (DI) Information

Proton Systems, LLC
18cm Wax Range Compensator

PROTON SYSTEMS VIRGINIA LLC
00861206000344
GS1
1
Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Radiation therapy beam block material A material designed for creating a custom-made beam block used to size, shape, or control depth of penetration of a beam of radiation delivered to a patient during radiation therapy treatments, to limit or eliminate exposure to non-target body areas. Beam block material is either: 1) a highly attenuating material, e.g., lead, cerrobend (Wood’s metal), or Rose's metal (aperture type); or 2) a material such as acrylic or wax that can be used to control the beam energy delivery depth. It can be cut or moulded into specific configurations to shape/define/attenuate the radiation beam, and is typically remelted for reuse after the patient treatment is considered finished.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, Linear, Medical
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
December 02, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE