Cervical Sleeve IU 6.4mm diameter, 40mm diameter, with marker GM11011290

GUDID 00816389026049

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389026049
NIH Device Record Key31733a56-8122-4595-9e60-3f894d2456fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervical Sleeve IU 6.4mm diameter, 40mm diameter, with marker
Version Model NumberGM11011290
Catalog NumberGM11011290
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

Length40 Millimeter
Length40 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389026049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389026049]

Moist Heat or Steam Sterilization


[00816389026049]

Moist Heat or Steam Sterilization


[00816389026049]

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.