Flexible Fixation Device for Gynecological Applicators GM11001960

GUDID 00816389029057

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389029057
NIH Device Record Keye0ae2021-5c08-4792-8c38-61dd1dce6e52
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 Exempttrue
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 Datetrue
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
GS100816389029057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


[00816389029057]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-18
Device Publish Date2021-10-10

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

00816389022119GM11001960
00816389029057GM11001960

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