Interstitial ovoid pair for 30mm spread, with fixation for guide tubes GM11013450

GUDID 00816389027992

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389027992
NIH Device Record Key0920b0eb-8bfe-40ce-87fc-df84cfc2ee46
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterstitial ovoid pair for 30mm spread, with fixation for guide tubes
Version Model NumberGM11013450
Catalog NumberGM11013450
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 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
GS100816389027992 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


[00816389027992]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-29
Device Publish Date2025-05-21

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00816389027978 - Interstitial ovoid pair for 20mm spread, with fixation for guide tubes2025-05-29
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
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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