Kelowna GYN Template 16 G GM11012210

GUDID 00816389020054

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389020054
NIH Device Record Key71af0631-2b3e-41fc-896f-0c0521da4787
Commercial Distribution StatusIn Commercial Distribution
Brand NameKelowna GYN Template 16 G
Version Model NumberGM11012210
Catalog NumberGM11012210
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
GS100816389020054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389020054]

Moist Heat or Steam Sterilization


[00816389020054]

Moist Heat or Steam Sterilization


[00816389020054]

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

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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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