SIR-Spheres Y-90 resin microspheres

Primary DI

00850014612153

Brand

SIR-Spheres Y-90 resin microspheres

Company

SIRTEX MEDICAL PTY LTD

Model

SIR-Y003

Device description

SIR-Y003 (0.6 Gbq/1 mL): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 0.6 GBq of Y90 ± 10% (at the time of calibration) in a total of 1 cc water for injection. 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.

Published

2026-05-28

Public version status

New

Distribution status

In Commercial Distribution

MRI safety

MR Safe

Rx

true

OTC

false

Sterile

true

Single use

true