AccessGUDID - DEVICE: Proton Systems, LLC (00861206000351)

GUDID

Device Identifier (DI) Information

Brand Name: Proton Systems, LLC
Version or Model: 25cm Brass 360 Apertrure
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROTON SYSTEMS VIRGINIA LLC

Primary DI Number: 00861206000351
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048148197 *Terms of Use

Device Description: Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42274	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121657	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4a287b9-106f-4eb0-bd3a-ee5521726017
Public Version Date: March 01, 2021
Public Version Number: 3
DI Record Publish Date: December 02, 2016