Tungsten alloy shielding 180 degrees GM11003880

GUDID 00816389022911

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389022911
NIH Device Record Key2fe9af65-4202-4fee-94e3-f5a59e40f751
Commercial Distribution StatusIn Commercial Distribution
Brand NameTungsten alloy shielding 180 degrees
Version Model NumberGM11003880
Catalog NumberGM11003880
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 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 Dimensions

Angle180 degree
Angle180 degree
Angle180 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389022911 [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 Date2016-09-22

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