Unique Single Energy Medical Charged Particle Radiation Therapy System CLL001009000

GUDID 00857235006013

VARIAN MEDICAL SYSTEMS, INC.

Linear accelerator system
Primary Device ID00857235006013
NIH Device Record Keye7df05e2-dfbe-4ed3-971a-d8b678b3d6c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnique Single Energy Medical Charged Particle Radiation Therapy System
Version Model Number9.1
Catalog NumberCLL001009000
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
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 Numberfalse
Manufacturing Datefalse
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
GS100857235006013 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-17
Device Publish Date2020-02-07

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT)2024-10-07
00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT)2024-10-07
00858086006481 - Varian Collimator Accessories 20 cm wedge set lower2024-10-07
00858086006498 - Varian Collimator Accessories Lead wedge set lower (JITKIT)2024-10-07

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