VariSeed 9.0

GUDID 00850800006005

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software
Primary Device ID00850800006005
NIH Device Record Key88720685-7cc2-441a-a6e0-872dfb37aea4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariSeed 9.0
Version Model Number9.0
Company DUNS035520894
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
GS100850800006005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem,planning,radiation therapy treatment

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 Date2016-11-08

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

00850800006074 - Vitesee2024-11-11
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
00858086006504 - Varian Collimator Accessories Lead wedge set upper (JITKIT)2024-10-07
00858086006511 - Varian Collimator Accessories Upper port film graticule for MLC2024-10-07
00858086006528 - Varian Collimator Accessories Upper port film graticule for MLC2024-10-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.