SIROS Delivery Set SIR-10300

GUDID 00850014612023

Sterile disposable tubing designed to provide proper routing of SIR-Spheres

SIRTEX MEDICAL PTY LTD

General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual General-purpose brachytherapy system applicator, manual
Primary Device ID00850014612023
NIH Device Record Key3a8e4b3f-c03e-4e03-8139-22321150ffc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIROS Delivery Set
Version Model NumberSIR-10300
Catalog NumberSIR-10300
Company DUNS755092467
Company NameSIRTEX MEDICAL PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]
GS100850014612023 [Primary]

FDA Product Code

IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual
IWJSystem, Applicator, Radionuclide, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by SIRTEX MEDICAL PTY LTD

00850014612009 - SIROS Delivery Dome2021-01-13 Delivery Dome for the administration of SIR-Spheres
00850014612016 - SIROS D-Vial Prep Set2021-01-13 Set for the preparation of SIR-Spheres
00850014612023 - SIROS Delivery Set2021-01-13Sterile disposable tubing designed to provide proper routing of SIR-Spheres
00850014612023 - SIROS Delivery Set2021-01-13 Sterile disposable tubing designed to provide proper routing of SIR-Spheres
M425SIRY0010 - SIR-Spheres microspheres2021-01-12 SIR-Spheres microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns

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