Device
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. Ea...
Manufacturer
SIRTEX MEDICAL PTY LTD
SIRTEX MEDICAL PTY LTD
Model: SIR-Y003
DI: 00850014612153
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
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.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a2c63a7d-c134-4f25-8bf0-c6d6de3f1bb7
Distribution Status:
In Commercial Distribution
DUNS Number:
755092467
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850014612153
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38303
Name: Manual brachytherapy source, permanent implant
Definition:
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
FDA Product Codes
NAW
Microspheres Radionuclide
Premarket Submissions
Submission Number:
P990065
Supplement Number:
019
Device Sizes
Device Size - Size - @attributes - Unit:
Milliliter
Device Size - Size - @attributes - Value:
1
Device Size - Size Type:
Total Volume