SIROS Delivery Dome SIR-10100

GUDID 00850014612009

Delivery Dome for the administration 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 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: 00850014612009
• NIH Device Record Key: 5cfed878-bf63-45f7-a14b-9154c9d8da5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIROS Delivery Dome
• Version Model Number: SIR-10100
• Catalog Number: SIR-10100
• 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: false
• 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

Customer Support Contacts

• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com
• Phone: 1-888-474-7839
• Email: info-us@sirtex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014612009 [Primary]

FDA Product Code

• IWJ: System, Applicator, Radionuclide, Manual

Sterilization

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

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

• 00850014612146 - SIR-Spheres Select Y-90 resin microspheres: 2024-04-05 SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Select Y-90 resin microspheres, also called SIR-Spheres Select, consist of biocompatible resi
• 00850014612108 - SIR-Spheres® Microspheres Activity Calculator (SMAC): 2021-08-24 Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
• 00850014612061 - SIR-Spheres V-Vial: 2021-07-23 SIR-Spheres V-Vial
• 00850014612047 - SIR-Spheres Delivery Apparatus: 2021-07-22 Delivery Apparatus for the administration of SIR-Spheres
• 00850014612054 - SIR-Spheres Delivery Set: 2021-07-22 Sir-Spheres delivery set
• 00850014612078 - SIR-Spheres V-Vial Holder: 2021-07-22 SIR-Spheres V-Vial Holder
• 00850014612092 - SIR-Spheres Accessories Pack: 2021-07-22 Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
• 00850014612085 - SIR-Spheres Syringe Shield: 2021-07-19 SIR-Spheres Syringe Shield