Varian Universal Titanium Cervix Probe Set, even lengths GM11013100

GUDID 00816389027619

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389027619
NIH Device Record Keye4270ed0-75ae-4152-91d6-64f29f857d68
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarian Universal Titanium Cervix Probe Set, even lengths
Version Model NumberGM11013100
Catalog NumberGM11013100
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100816389027619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389027619]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-08
Device Publish Date2019-10-31

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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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