Transfer Guide Tube for 200 mm catheters GM11011870

GUDID 00816389027565

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389027565
NIH Device Record Keyd8226eb8-8bed-43d1-bba9-6058fa638303
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransfer Guide Tube for 200 mm catheters
Version Model NumberGM11011870
Catalog NumberGM11011870
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
GS100816389027565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-29
Device Publish Date2019-04-20

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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00810563021943 - Heyman capsule MR safe, 8 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563022834 - Intraluminal Applicator Set2024-10-08 Intraluminal Applicator Set
10816389027180 - Protection caps, blue (pack of 20)2024-05-03
10816389027210 - Sterilization plug, black (pack of 25)2024-05-03

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