SIR-Spheres microspheres SIR-Y001

GUDID M425SIRY0010

SIR-Spheres microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.

SIRTEX MEDICAL PTY LTD

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• Primary Device ID: M425SIRY0010
• NIH Device Record Key: 1c525593-b6b4-4ec3-b31e-f3ba0dc434dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIR-Spheres microspheres
• Version Model Number: SIR-Y001
• Catalog Number: SIR-Y001
• Company DUNS: 755092467
• Company Name: SIRTEX MEDICAL PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@sirtex.com
• Phone: +61407877949
• Email: qa@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
• 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 Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
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• Total Volume: 5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M425SIRY0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990065

FDA Product Code

• NAW: Microspheres Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-12
• Device Publish Date: 2014-09-24

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