X-ray marker BV, up to 320 mm applicators, uncoded GM11009600

GUDID 00816389024861

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389024861
NIH Device Record Key940fbee8-00fb-4468-8cf2-08888b576fcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray marker BV, up to 320 mm applicators, uncoded
Version Model NumberGM11009600
Catalog NumberGM11009600
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100816389024861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389024861]

Moist Heat or Steam Sterilization


[00816389024861]

Moist Heat or Steam Sterilization


[00816389024861]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [X-ray marker BV, up to 320 mm applicators, uncoded]

00816389024861GM11009600
00816389029118GM11009600

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