Ovoid \ cervical stop set screw (pack of 8) AL07335000

GUDID 00810563022933

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00810563022933
NIH Device Record Key76aec048-bf71-4224-9608-a69944d94991
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvoid \ cervical stop set screw (pack of 8)
Version Model NumberAL07335000
Catalog NumberAL07335000
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count8
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
GS100810563022933 [Unit of Use]
GS110810563022930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

Moist Heat or Steam Sterilization


[00810563022933]

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

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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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
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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