Front segment open 20 mm diameter, 15 degrees curved, length 60 mm GM11004200

GUDID 00816389023031

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 ID00816389023031
NIH Device Record Key2853e3fa-d6b0-4a89-8478-b1c0c0129ba9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFront segment open 20 mm diameter, 15 degrees curved, length 60 mm
Version Model NumberGM11004200
Catalog NumberGM11004200
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

Outer Diameter20 Millimeter
Outer Diameter20 Millimeter
Outer Diameter20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389023031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389023031]

Moist Heat or Steam Sterilization


[00816389023031]

Moist Heat or Steam Sterilization


[00816389023031]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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
20816389020362 - Transfer Guide Tube + of 1000 mm length for catheters2024-02-28
10816389020372 - Transfer Guide Tube + of 1000 mm length for Luer connections2024-02-28

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