Proton Systems, LLC

GUDID 00861206000351

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.

PROTON SYSTEMS VIRGINIA LLC

Radiation therapy beam block material
Primary Device ID00861206000351
NIH Device Record Keyf4a287b9-106f-4eb0-bd3a-ee5521726017
Commercial Distribution StatusIn Commercial Distribution
Brand NameProton Systems, LLC
Version Model Number25cm Brass 360 Apertrure
Company DUNS048148197
Company NamePROTON SYSTEMS VIRGINIA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861206000351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-02

On-Brand Devices [Proton Systems, LLC]

00861206000382Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and desig
00861206000375Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and
00861206000368Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and desig
00861206000351Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and
00861206000344Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and desig
00861206000337Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and

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