Mini-colpostat segments, pair GM11000900

GUDID 00810563022360

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00810563022360
NIH Device Record Key58cf1431-d9f2-4bb1-80c7-d248df55ee98
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini-colpostat segments, pair
Version Model NumberGM11000900
Catalog NumberGM11000900
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
GS100810563022360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


[00810563022360]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-11
Device Publish Date2023-10-03

Devices Manufactured by Varian Medical Systems Deutschland GmbH

00810563023022 - Titanium Allen wrench2025-05-29
00816389027961 - Interstitial mini ovoid pair, with fixation for guide tubes2025-05-29
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
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.