VariSeed

GUDID 00850800006067

VARIAN MEDICAL SYSTEMS, INC.

Radiation therapy software
Primary Device ID00850800006067
NIH Device Record Key0f24ab32-f57b-4514-b839-56aa296707a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariSeed
Version Model Number10.0
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 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
GS100850800006067 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-15

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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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
00858086006535 - Varian Collimator Accessories Lower port film graticule for MLC2024-10-07

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