Afterloader Basic Device GammaMedplus 230 Volt, Series iX GM84000280

GUDID 00816389020399

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy system
Primary Device ID00816389020399
NIH Device Record Key6fbe59f4-648d-4213-82fe-a8f6a688d8c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAfterloader Basic Device GammaMedplus 230 Volt, Series iX
Version Model NumberGM84000280
Catalog NumberGM84000280
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100816389020399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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