SIR-Spheres Y-90 resin microspheres

GUDID 00850014612030

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 PTY LTD

Manual brachytherapy source, permanent implant
Primary Device ID00850014612030
NIH Device Record Key5e479eb1-2400-43eb-a1be-e4f980bf6a24
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIR-Spheres Y-90 resin microspheres
Version Model NumberSIR-Y001
Company DUNS755092467
Company NameSIRTEX MEDICAL PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com
Phone1-888-474-7839
Emailinfo-us@sirtex.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014612030 [Primary]
HIBCCM425SIRY0010 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAWMicrospheres Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-23
Device Publish Date2024-07-15

Devices Manufactured by SIRTEX MEDICAL PTY LTD

00850014612030 - SIR-Spheres Y-90 resin microspheres2024-07-23SIR-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.
00850014612030 - SIR-Spheres Y-90 resin microspheres2024-07-23 SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with
00850014612146 - SIR-Spheres Select Y-90 resin microspheres2024-04-05 SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Select Y-90 resin microspheres, also called SIR-Spheres Select, consist of biocompatible resi
00850014612108 - SIR-Spheres® Microspheres Activity Calculator (SMAC)2021-08-24 Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
00850014612061 - SIR-Spheres V-Vial2021-07-23 SIR-Spheres V-Vial
00850014612047 - SIR-Spheres Delivery Apparatus2021-07-22 Delivery Apparatus for the administration of SIR-Spheres
00850014612054 - SIR-Spheres Delivery Set 2021-07-22 Sir-Spheres delivery set
00850014612078 - SIR-Spheres V-Vial Holder2021-07-22 SIR-Spheres V-Vial Holder
00850014612092 - SIR-Spheres Accessories Pack2021-07-22 Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
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