Applicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm GM11011610

GUDID 00816389026278

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389026278
NIH Device Record Key119fce94-f518-4481-ac1b-88b86571ecbc
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator probe, 6.3 mm diameter x 320 mm, curved 15 degrees, 60 mm
Version Model NumberGM11011610
Catalog NumberGM11011610
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Angle15 degree
Angle15 degree
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389026278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389026278]

Moist Heat or Steam Sterilization


[00816389026278]

Moist Heat or Steam Sterilization


[00816389026278]

Moist Heat or Steam Sterilization


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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