Ovoid mini Ø16 mm Left GM94066760

GUDID 00810563023008

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00810563023008
NIH Device Record Key317321af-e2f0-4d91-bacd-7d86ddadb5e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvoid mini Ø16 mm Left
Version Model NumberGM94066760
Catalog NumberGM94066760
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
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
GS100810563023008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


[00810563023008]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-30
Device Publish Date2025-05-22

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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00810563023008 - Ovoid mini Ø16 mm Left2025-05-30
00810563023008 - Ovoid mini Ø16 mm Left2025-05-30
00810563023015 - Ovoid mini Ø16 mm Right2025-05-30
00855141006417 - MaximQA2025-03-12
00858086006818 - IDENTIFY2025-03-05
30816389027290 - Fixation buttons, pack of 10, sterile2025-02-21
00855141006349 - Eclipse Treatment Planning System2024-12-30

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