Flexible Fixation Device for Gynecological Applicators GM11001960

GUDID 00816389022119

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389022119
NIH Device Record Keyc5dd757b-57bc-44c4-b414-95bf64b5c91a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Fixation Device for Gynecological Applicators
Version Model NumberGM11001960
Catalog NumberGM11001960
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 Identifiers

Device Issuing AgencyDevice ID
GS100816389022119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389022119]

Moist Heat or Steam Sterilization


[00816389022119]

Moist Heat or Steam Sterilization


[00816389022119]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [Flexible Fixation Device for Gynecological Applicators]

00816389022119GM11001960
00816389029057GM11001960

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