SIRTEX MEDICAL INC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• sirtex.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• SIR-Spheres Y-90 resin microspheres

  2022-04-12

  Sirtex Medical Pty Ltdshop 6 207 Pacific Highwayst Leonards, New South Wales 2065 PMA NumberP990065 Supplement NumberS012 Date Received03/21/2022 Decision Date04/12/2022 Product Code NAW  Advisory Committee Radiology Supplement Type30-day Notice Supplement ...

• SIR-Spheres microspheres

  2017-03-24

  Sirtex Medical Pty Ltd

• SIR-SPHERES MICROSPHERES

  2017-01-18

  Sirtex Medical Pty Ltd

• SIR-SPHERES MICROSPHERES

  2015-02-27

  Sirtex Medical Pty Ltd

• SIR-SPHERE MICROSPHERES

  2014-10-09

  Sirtex Medical Pty Ltd

• SIR-SPHERES

  2012-07-17

  Sirtex Medical Pty Ltd

• SIR-SPHERES

  2008-01-18

  Sirtex Medical Pty Ltd

• SIR-SPHERES

  2003-04-24

  Sirtex Medical Pty Ltd

• SIR-SPHERES

  2002-03-05

  Sirtex Medical Pty Ltd

PMN#

• SIR-Spheres Microspheres Activity Calculator (SMAC)

  2020-10-23

  Sirtex Medical US Holdings Inc.

GUDID#

• LAVA-18, 2 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-18, 2 mL

  Sirtex Medical Inc.

  2023-10-23

• LAVA-34, 2 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-34, 2 mL

  Sirtex Medical Inc.

  2023-10-23

• LAVA-18, 6 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-18, 6 mL

  Sirtex Medical Inc.

  2023-10-23

• LAVA-34, 6 mL - LAVA Liquid Embolic System (LES) Kit, LAVA-34, 6 mL

  Sirtex Medical Inc.

  2023-10-23

• LAVA Mixing Kit, 2 mL - LAVA Mixing Kit, 2 mL (to homogenize the liquid embolic suspension)

  Sirtex Medical Inc.

  2023-10-23

• LAVA Mixing Kit, 6 mL - LAVA Mixing Kit, 6 mL (to homogenize the liquid embolic suspension)

  Sirtex Medical Inc.

  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.

  Sirtex Medical Inc.

  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.

  Sirtex Medical Inc.

  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.

  Sirtex Medical Inc.

  2024-03-28

• SIR-Spheres® Microspheres Activity Calculator (SMAC) - Dose activity calculator for Selective Internal Radiation Therapy (SIRT)

  Sirtex Medical Inc.

  2021-08-16

• SIR-Spheres V-Vial - SIR-V001

  Sirtex Medical Inc.

  2021-07-15

• SIR-Spheres Delivery Apparatus - Delivery Apparatus for the administration of SIR-Spheres

  Sirtex Medical Inc.

  2021-07-14

• SIR-Spheres Delivery Set - SIR-D001

  Sirtex Medical Inc.

  2021-07-14

• SIR-Spheres V-Vial Holder - SIR-H001

  Sirtex Medical Inc.

  2021-07-14

• SIR-Spheres Accessories Pack - Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)

  Sirtex Medical Inc.

  2021-07-14

• SIR-Spheres Syringe Shield - SIR-S001

  Sirtex Medical Inc.

  2021-07-09

• SIROS Delivery Dome - Delivery Dome for the administration of SIR-Spheres

  Sirtex Medical Inc.

  2021-01-05

• SIROS D-Vial Prep Set - Set for the preparation of SIR-Spheres

  Sirtex Medical Inc.

  2021-01-05

• SIROS Delivery Set - Sterile disposable tubing designed to provide proper routing of SIR-Spheres

  Sirtex Medical Inc.

  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.

  Sirtex Medical Inc.

  2014-09-24