Primary Device ID | 00850014612009 |
NIH Device Record Key | 5cfed878-bf63-45f7-a14b-9154c9d8da5c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SIROS Delivery Dome |
Version Model Number | SIR-10100 |
Catalog Number | SIR-10100 |
Company DUNS | 755092467 |
Company Name | SIRTEX MEDICAL PTY LTD |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com | |
Phone | 1-888-474-7839 |
info-us@sirtex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850014612009 [Primary] |
IWJ | System, Applicator, Radionuclide, Manual |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-01-13 |
Device Publish Date | 2021-01-05 |
00850014612030 - SIR-Spheres Y-90 resin microspheres | 2024-07-23 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 microspheres | 2024-04-05 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-Vial | 2021-07-23 SIR-Spheres V-Vial |
00850014612047 - SIR-Spheres Delivery Apparatus | 2021-07-22 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 Holder | 2021-07-22 SIR-Spheres V-Vial Holder |
00850014612092 - SIR-Spheres Accessories Pack | 2021-07-22 Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder) |