Transfer Guide Tube + of 1000 mm length for applicators GM11014610

GUDID 10816389020327

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID10816389020327
NIH Device Record Keyc0980466-2b66-4387-8e93-47c67f8c3020
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransfer Guide Tube + of 1000 mm length for applicators
Version Model NumberGM11014610
Catalog NumberGM11014610
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 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
GS100816389020320 [Primary]
GS110816389020327 [Package]
Contains: 00816389020320
Package: [3 Units]
In Commercial Distribution

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 Date2024-02-28
Device Publish Date2024-02-20

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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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