VariSource iX(t) AL19004-001

GUDID 00856545006034

VARIAN MEDICAL SYSTEMS UK HOLDINGS LIMITED

Remote-afterloading brachytherapy system
Primary Device ID00856545006034
NIH Device Record Key35b1e9e6-622f-4a14-b51c-fc3358b71bee
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariSource iX(t)
Version Model Number1.2
Catalog NumberAL19004-001
Company DUNS516270597
Company NameVARIAN MEDICAL SYSTEMS UK HOLDINGS 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
GS100856545006034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

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 UK HOLDINGS LIMITED

00856545006027 - VariSource iX2018-07-06
00856545006034 - VariSource iX(t)2018-07-06
00856545006034 - VariSource iX(t)2018-07-06

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