Intrauterine tandem, 45 degrees, 8 cm, CT/ MR GM11012640

GUDID 00816389029576

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389029576
NIH Device Record Key85c98dc7-b14c-4c4b-97f6-9f62987f35f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntrauterine tandem, 45 degrees, 8 cm, CT/ MR
Version Model NumberGM11012640
Catalog NumberGM11012640
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100816389029576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


[00816389029576]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

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00816389027985 - Interstitial ovoid pair for 25mm spread, with fixation for guide tubes2025-05-29
00816389027992 - Interstitial ovoid pair for 30mm spread, with fixation for guide tubes2025-05-29
00810563022933 - Ovoid \ cervical stop set screw (pack of 8)2025-05-29
00810563022612 - Disassembly Pin, CT/ MR2025-05-26
00816389029439 - CT/ MR Tandem and Ovoid Set (CTO)2025-05-26

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