Fletcher-style Applicator Set Defined Geometry GM11000810

GUDID 00816389021693

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389021693
NIH Device Record Key76c4b625-77d1-425d-99f3-c14597777d1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFletcher-style Applicator Set Defined Geometry
Version Model NumberGM11000810
Catalog NumberGM11000810
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 Identifiers

Device Issuing AgencyDevice ID
GS100816389021693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389021693]

Moist Heat or Steam Sterilization


[00816389021693]

Moist Heat or Steam Sterilization


[00816389021693]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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10816389027210 - Sterilization plug, black (pack of 25)2024-05-03

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