Colpostat probe, left, CT/ MR GM11012660

GUDID 00816389029446

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389029446
NIH Device Record Key0f28c6fd-6974-45e0-aa54-4ea2ab953d59
Commercial Distribution StatusIn Commercial Distribution
Brand NameColpostat probe, left, CT/ MR
Version Model NumberGM11012660
Catalog NumberGM11012660
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100816389029446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


[00816389029446]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-26
Device Publish Date2025-05-16

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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

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