Titanium intrauterine probe with cervical stop, angle 30 degrees, length 80 mm GM11006180

GUDID 00816389023758

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389023758
NIH Device Record Key40534b75-550e-459b-a9da-b6d20cad2368
Commercial Distribution StatusIn Commercial Distribution
Brand NameTitanium intrauterine probe with cervical stop, angle 30 degrees, length 80 mm
Version Model NumberGM11006180
Catalog NumberGM11006180
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length80 Millimeter
Length80 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389023758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389023758]

Moist Heat or Steam Sterilization


[00816389023758]

Moist Heat or Steam Sterilization


[00816389023758]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by Varian Medical Systems Deutschland GmbH

10816389027180 - Protection caps, blue (pack of 20)2024-05-03
10816389027210 - Sterilization plug, black (pack of 25)2024-05-03
10816389024646 - Flexible implant tube, double leader, 530 mm, sterile, set of 32024-04-19
10816389020310 - Transfer Guide Tube + for 320 mm applicators2024-02-28
10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators2024-02-28
10816389020334 - Transfer Guide Tube + for 200 mm catheters2024-02-28
00816389020344 - Transfer Guide Tube + for 250 mm catheters2024-02-28
10816389020358 - Transfer Guide Tube + of 500 mm length for catheters2024-02-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.