Basic Accessory Kit for Intracavitary/GYN Applicators, GammaMed GM11008210

GUDID 00816389024571

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389024571
NIH Device Record Key13bf9126-155f-444f-8d93-da4dc2c10789
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasic Accessory Kit for Intracavitary/GYN Applicators, GammaMed
Version Model NumberGM11008210
Catalog NumberGM11008210
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
GS100816389024571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389024571]

Moist Heat or Steam Sterilization


[00816389024571]

Moist Heat or Steam Sterilization


[00816389024571]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-18

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

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