Surface Applicator Set with Leipzig-style Cone (HDR use only) GM11010080

GUDID 00816389025196

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389025196
NIH Device Record Key95013d2e-d7fe-4538-beab-54316b1291fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurface Applicator Set with Leipzig-style Cone (HDR use only)
Version Model NumberGM11010080
Catalog NumberGM11010080
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100816389025196 [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 Number5
Public Version Date2019-02-07
Device Publish Date2016-11-08

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