Thumbscrew for Kelowna GYN templates GM11012320

GUDID 00816389020153

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389020153
NIH Device Record Key0f7e3a2a-0a25-40a5-b7c1-60a6f1d585ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameThumbscrew for Kelowna GYN templates
Version Model NumberGM11012320
Catalog NumberGM11012320
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100816389020153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389020153]

Moist Heat or Steam Sterilization


[00816389020153]

Moist Heat or Steam Sterilization


[00816389020153]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-23

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

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