High-Definition 120 Multileaf Collimator

GUDID 00899475002110

VARIAN MEDICAL SYSTEMS, INC.

Automatic-aperture-control accelerator system collimator
Primary Device ID00899475002110
NIH Device Record Keyf5f201f2-844b-44d1-8abc-c82c0f07a02c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHigh-Definition 120 Multileaf Collimator
Version Model Number8.1
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 Batchfalse
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
GS100899475002110 [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 Number4
Public Version Date2026-01-14
Device Publish Date2016-09-10

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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