LEFT COLPOSTAT FLANGE (CT/MR FSD) AL10715001

GUDID 00816389020917

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389020917
NIH Device Record Key84a01154-0639-462d-bb26-686fde0e6218
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEFT COLPOSTAT FLANGE (CT/MR FSD)
Version Model NumberAL10715001
Catalog NumberAL10715001
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100816389020917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389020917]

Moist Heat or Steam Sterilization


[00816389020917]

Moist Heat or Steam Sterilization


[00816389020917]

Moist Heat or Steam Sterilization


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

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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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