Leak Stop Button (pack of 50), non-sterile GM11003810

GUDID 00816389022881

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389022881
NIH Device Record Keydf23821b-9480-4293-b5c7-8ee5e066a059
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeak Stop Button (pack of 50), non-sterile
Version Model NumberGM11003810
Catalog NumberGM11003810
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100816389022881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389022881]

Moist Heat or Steam Sterilization


[00816389022881]

Moist Heat or Steam Sterilization


[00816389022881]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-22

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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10816389027210 - Sterilization plug, black (pack of 25)2024-05-03
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10816389020310 - Transfer Guide Tube + for 320 mm applicators2024-02-28
10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators2024-02-28
10816389020334 - Transfer Guide Tube + for 200 mm catheters2024-02-28
00816389020344 - Transfer Guide Tube + for 250 mm catheters2024-02-28
10816389020358 - Transfer Guide Tube + of 500 mm length for catheters2024-02-28

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