Bravos HDR Ir 192 Brachytherapy Sealed Source VG32203000

GUDID 00816389028852

Varian Medical Systems Deutschland GmbH

Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source Remote-afterloading brachytherapy source
Primary Device ID00816389028852
NIH Device Record Key96af5507-baca-4f5a-8a64-4c59f470f187
Commercial Distribution StatusIn Commercial Distribution
Brand NameBravos HDR Ir 192 Brachytherapy Sealed Source
Version Model NumberVG32203000
Catalog NumberVG32203000
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
GS100816389028852 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-17
Device Publish Date2022-01-09

Devices Manufactured by Varian Medical Systems Deutschland GmbH

10816389024646 - Flexible implant tube, double leader, 530 mm, sterile, set of 32024-04-19
10816389020310 - Transfer Guide Tube + for 320 mm applicators2024-02-28
10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators2024-02-28
10816389020334 - Transfer Guide Tube + for 200 mm catheters2024-02-28
00816389020344 - Transfer Guide Tube + for 250 mm catheters2024-02-28
10816389020358 - Transfer Guide Tube + of 500 mm length for catheters2024-02-28
20816389020362 - Transfer Guide Tube + of 1000 mm length for catheters2024-02-28
10816389020372 - Transfer Guide Tube + of 1000 mm length for Luer connections2024-02-28

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