Intrauterine tandems, right and left, 320 mm length, angle 20 degrees x 90 mm GM11009890

GUDID 00816389025080

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389025080
NIH Device Record Key2b95ecd3-7b6e-4d7b-a50c-9cd0310e2cec
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntrauterine tandems, right and left, 320 mm length, angle 20 degrees x 90 mm
Version Model NumberGM11009890
Catalog NumberGM11009890
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 Dimensions

Length90 Millimeter
Length90 Millimeter
Length90 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389025080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389025080]

Moist Heat or Steam Sterilization


[00816389025080]

Moist Heat or Steam Sterilization


[00816389025080]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by Varian Medical Systems Deutschland GmbH

00810563021868 - Ring probe (2021), Ø 26 x 45°2025-04-03
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

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