Duns Number:755092467
Device Description: SIR-Spheres microspheres consist of biocompatible resin microspheres containing yttrium-90 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.
Catalog Number
SIR-Y001
Brand Name
SIR-Spheres microspheres
Version/Model Number
SIR-Y001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P990065
Product Code
NAW
Product Code Name
Microspheres Radionuclide
Public Device Record Key
1c525593-b6b4-4ec3-b31e-f3ba0dc434dc
Public Version Date
January 19, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 1 |