Headless Screw Titanium for ovoids, (pack of 10) GM11007250

GUDID 00810563022513

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00810563022513
NIH Device Record Key342f6000-888d-4258-a5aa-b0a2c361193a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeadless Screw Titanium for ovoids, (pack of 10)
Version Model NumberGM11007250
Catalog NumberGM11007250
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exempttrue
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
GS100810563022513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


[00810563022513]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-27
Device Publish Date2024-11-19

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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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