X-ray marker BV set I, up to 500 mm tubes, coded 01-06 GM11009670

GUDID 00816389024939

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389024939
NIH Device Record Keybec7fc99-a7c4-4410-b616-8e76b8b821bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-ray marker BV set I, up to 500 mm tubes, coded 01-06
Version Model NumberGM11009670
Catalog NumberGM11009670
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

Length500 Millimeter
Length500 Millimeter
Length500 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389024939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389024939]

Moist Heat or Steam Sterilization


[00816389024939]

Moist Heat or Steam Sterilization


[00816389024939]

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 I, up to 500 mm tubes, coded 01-06]

00816389024939GM11009670
00816389029187GM11009670

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