Leak Stop Button (pack of 50) GM11003810

GUDID 00816389028326

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389028326
NIH Device Record Keydc1df99c-b753-4cb9-ad75-7f0c9ea447c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeak Stop Button (pack of 50)
Version Model NumberGM11003810
Catalog NumberGM11003810
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count50
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100816389028326 [Unit of Use]
GS110816389028323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


[00816389028326]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-27
Device Publish Date2020-11-13

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