ProBeam 360 Proton Therapy System - Rotaiting Gantry

GUDID 00858991006071

Varian Medical Systems Particle Therapy GmbH

Proton therapy system
Primary Device ID00858991006071
NIH Device Record Key7d06968b-1d16-4d2f-9819-fc5a6378c381
Commercial Distribution StatusIn Commercial Distribution
Brand NameProBeam 360 Proton Therapy System - Rotaiting Gantry
Version Model Number1.0
Company DUNS342623907
Company NameVarian Medical Systems Particle Therapy GmbH
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858991006071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHNSystem, radiation therapy, charged-particle, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

Devices Manufactured by Varian Medical Systems Particle Therapy GmbH

00858991006088 - ProBeam 360 Proton Therapy System - Rotating Gantry2023-11-02
00858991006071 - ProBeam 360 Proton Therapy System - Rotaiting Gantry2022-12-14
00858991006071 - ProBeam 360 Proton Therapy System - Rotaiting Gantry2022-12-14
00858991006026 - ProBeam® Fixed Beam Proton Therapy System2019-10-04 Fixed Beam
00858991006033 - ProBeam® Rotating Gantry Proton Therapy System2019-10-04 Rotating Gantry
00858991006040 - ProBeam® Rotating Gantry Proton Therapy System2019-10-04
00858991006002 - ProBeam Proton Therapy System2018-07-06 Rotating Gantry
00858991006019 - ProBeam Proton Therapy System2018-07-06 Fixed Beam

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