X-ray marker BV set Intraluminal, up to 1300 mm length, coded 01-03 GM11009660

GUDID 00816389024922

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389024922
NIH Device Record Key42452167-5871-4335-9b3e-dd42d73c71c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray marker BV set Intraluminal, up to 1300 mm length, coded 01-03
Version Model NumberGM11009660
Catalog NumberGM11009660
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 Dimensions

Length1300 Millimeter
Length1300 Millimeter
Length1300 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389024922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389024922]

Moist Heat or Steam Sterilization


[00816389024922]

Moist Heat or Steam Sterilization


[00816389024922]

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 set Intraluminal, up to 1300 mm length, coded 01-03]

00816389024922GM11009660
00816389029170GM11009660

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