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 ID: 00850014612023
• NIH Device Record Key: 3a8e4b3f-c03e-4e03-8139-22321150ffc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIROS Delivery Set
• Version Model Number: SIR-10300
• Catalog Number: SIR-10300
• Company DUNS: 755092467
• Company Name: SIRTEX MEDICAL PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]
GS1	00850014612023 [Primary]

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual
• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-13
• Device Publish Date: 2021-01-05

Devices Manufactured by SIRTEX MEDICAL PTY LTD

• 00850014612009 - SIROS Delivery Dome: 2021-01-13 Delivery Dome for the administration of SIR-Spheres
• 00850014612016 - SIROS D-Vial Prep Set: 2021-01-13 Set for the preparation of SIR-Spheres
• 00850014612023 - SIROS Delivery Set: 2021-01-13Sterile disposable tubing designed to provide proper routing of SIR-Spheres
• 00850014612023 - SIROS Delivery Set: 2021-01-13 Sterile disposable tubing designed to provide proper routing of SIR-Spheres
• M425SIRY0010 - SIR-Spheres microspheres: 2021-01-12 SIR-Spheres microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns