Source guide tube with locking mechanism for 113 mm needles, GammaMedplus GM11000520

GUDID 00816389021570

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389021570
NIH Device Record Key41169e57-fcb1-4e0c-b2bf-aea403d8dd89
Commercial Distribution StatusIn Commercial Distribution
Brand NameSource guide tube with locking mechanism for 113 mm needles, GammaMedplus
Version Model NumberGM11000520
Catalog NumberGM11000520
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 Dimensions

Length113 Millimeter
Length113 Millimeter
Length113 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389021570 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by Varian Medical Systems Deutschland GmbH

00810563022346 - Titanium Fletcher style Applicator Set Defined Geometry2024-11-27
00810563022421 - Smit cervical sleeves ø 3 mm, 30mm length, with marker2024-11-27
00810563022438 - Smit cervical sleeves ø 3 mm, 40mm length, with marker2024-11-27
00810563022445 - Smit cervical sleeves ø 3 mm, 50mm length, with marker2024-11-27
00810563022452 - Smit cervical sleeves ø 3 mm, 60mm length, with marker2024-11-27
00810563022469 - Smit cervical sleeves ø 3 mm, 70mm length, with marker2024-11-27
00810563022476 - Smit cervical sleeves ø 3 mm, 80mm length, with marker2024-11-27
00810563022483 - Fixation for 3 channel applicators, for adjustable holder2024-11-27

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.