GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source GM12000680

GUDID 00816389028838

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy source
Primary Device ID00816389028838
NIH Device Record Key30a9afa1-e06d-434b-808b-7748ef8c002a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source
Version Model NumberGM12000680
Catalog NumberGM12000680
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exempttrue
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
GS100816389028838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, brachytherapy, radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-17
Device Publish Date2022-01-09

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