TANDEM ROTATE & SLIDE BLOCK (CT/MR FSD) AL10715008

GUDID 00816389020986

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389020986
NIH Device Record Keya6d2b470-b865-4b98-a188-5db1ef5a6735
Commercial Distribution StatusIn Commercial Distribution
Brand NameTANDEM ROTATE & SLIDE BLOCK (CT/MR FSD)
Version Model NumberAL10715008
Catalog NumberAL10715008
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
GS100816389020986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389020986]

Moist Heat or Steam Sterilization


[00816389020986]

Moist Heat or Steam Sterilization


[00816389020986]

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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00810563021875 - Ring probe (2021), Ø 30 x 45°2025-04-03
00810563021882 - Ring probe (2021), Ø 26 x 60°2025-04-03
00810563021899 - Ring probe (2021), Ø 30 x 60°2025-04-03
00810563021905 - Ring probe (2021), Ø 26 x 90°2025-04-03
00810563021912 - Ring probe (2021), Ø 30 x 90°2025-04-03
00810563022841 - Fixation ring for cylinder ø 20 mm2025-04-03
00810563022858 - Fixation ring for cylinder ø 23 mm2025-04-03

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