Varian Treatment

GUDID 00856104006000

VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED

Radiation therapy treatment record/verify system
Primary Device ID00856104006000
NIH Device Record Key3df333bf-6bf5-4979-8da4-2d616cb702c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarian Treatment
Version Model Number13.0
Company DUNS863318313
Company NameVARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856104006000 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED

00856104006079 - Varian Verification Console2019-11-18
00856104006123 - Varian Verification Console2019-11-18
00856104006000 - Varian Treatment2018-07-06
00856104006000 - Varian Treatment2018-07-06
00856104006017 - Varian Verification System (VVS)2018-07-06
00856104006024 - Verification Console2018-07-06

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