sirtex.comSIR-Spheres® Microspheres Activity Calculator (SMAC) - Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
2021-08-16
SIRTEX MEDICAL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012690638 | 3012690638 | SIRTEX MEDICAL INC. | 1 | N | 2026-01-01 | 300 Unicorn Park Dr., 2nd Fl., Woburn MA US 01801 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850014612108 | SIR-Spheres® Microspheres Activity Calculator (SMAC) - Dose activity calculator for Selective Internal Radiation Therapy (SIRT) | 1-888-474-7839 | info-us@sirtex.com |
| 00850014612153 | SIR-Spheres Y-90 resin microspheres - 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. | 1-888-474-7839 | info-us@sirtex.com |
| 00850055697003 | LAVA-18, 2 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL | 1-888-474-7839 | csusa@sirtex.com |
| 00850055697010 | LAVA-34, 2 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-34, 2 mL | 1-888-474-7839 | csusa@sirtex.com |
| 00850055697027 | LAVA-18, 6 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-18, 6 mL | 1-888-474-7839 | csusa@sirtex.com |
| 00850055697034 | LAVA-34, 6 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-34, 6 mL | 1-888-474-7839 | csusa@sirtex.com |
| 00850055697041 | LAVA Mixing Kit, 2 mL - LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension) | 1-888-474-7839 | csusa@sirtex.com |
| 00850055697058 | LAVA Mixing Kit, 6 mL - LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension) | 1-888-474-7839 | csusa@sirtex.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 345613 | 1920172198 | P990065 | SIR-SPHERES | NAW | 2002-03-05 |
| 345613 | 1865088011 | P220020 | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit | QVG | 2023-04-04 |
| 345613 | 1691803870 | K202392 | SIR-Spheres Microspheres Activity Calculator (SMAC) | KPS | 2020-10-23 |
| 345613 | 1496239358 | ||||
| 345613 | 1620443216 | ||||
| 345613 | 1664110596 | ||||
| 345613 | 1871622136 |
Product Codes Associated With Registrations#
GUDID#
LAVA-18, 2 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL
2023-10-23
LAVA-34, 2 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-34, 2 mL
2023-10-23
LAVA-18, 6 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-18, 6 mL
2023-10-23
LAVA-34, 6 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-34, 6 mL
2023-10-23
LAVA Mixing Kit, 2 mL - LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension)
2023-10-23
LAVA Mixing Kit, 6 mL - LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)
2023-10-23
SIR-Spheres Y-90 resin microspheres - 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.
2026-05-28
SIR-Spheres Y-90 resin microspheres - SIR-Y001 (3Gbq/5ml): 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 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 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.
2024-07-15
SIR-Spheres Y-90 resin microspheres - SIR-Y002 (1.8Gbq/3ml): 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 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 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.
2024-03-28
SIR-Spheres V-Vial - SIR-V001
2021-07-15
SIR-Spheres Delivery Apparatus - Delivery Apparatus for the administration of SIR-Spheres
2021-07-14
SIR-Spheres Delivery Set - SIR-D001
2021-07-14
SIR-Spheres V-Vial Holder - SIR-H001
2021-07-14
SIR-Spheres Accessories Pack - Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
2021-07-14
SIR-Spheres Syringe Shield - SIR-S001
2021-07-09
SIROS Delivery Dome - Delivery Dome for the administration of SIR-Spheres
2021-01-05
SIROS D-Vial Prep Set - Set for the preparation of SIR-Spheres
2021-01-05
SIROS Delivery Set - Sterile disposable tubing designed to provide proper routing of SIR-Spheres
2021-01-05
SIR-Spheres microspheres - SIR-Y001 (3Gbq/5ml): SIR-Spheres Y90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 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.
2014-09-24