Kelowna GYN Template 2,0mm GM11012200

GUDID 00816389020047

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389020047
NIH Device Record Keye561143f-8e27-4395-95d4-231ea8ed879b
Commercial Distribution StatusIn Commercial Distribution
Brand NameKelowna GYN Template 2,0mm
Version Model NumberGM11012200
Catalog NumberGM11012200
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Identifiers

Device Issuing AgencyDevice ID
GS100816389020047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389020047]

Moist Heat or Steam Sterilization


[00816389020047]

Moist Heat or Steam Sterilization


[00816389020047]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-23

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