Primary Device ID | 00850014612023 |
NIH Device Record Key | 3a8e4b3f-c03e-4e03-8139-22321150ffc7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SIROS Delivery Set |
Version Model Number | SIR-10300 |
Catalog Number | SIR-10300 |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
GS1 | 00850014612023 [Primary] |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
IWJ | System, Applicator, Radionuclide, Manual |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-01-13 |
Device Publish Date | 2021-01-05 |
00850014612009 - SIROS Delivery Dome | 2021-01-13 Delivery Dome for the administration of SIR-Spheres |
00850014612016 - SIROS D-Vial Prep Set | 2021-01-13 Set for the preparation of SIR-Spheres |
00850014612023 - SIROS Delivery Set | 2021-01-13Sterile disposable tubing designed to provide proper routing of SIR-Spheres |
00850014612023 - SIROS Delivery Set | 2021-01-13 Sterile disposable tubing designed to provide proper routing of SIR-Spheres |
M425SIRY0010 - SIR-Spheres microspheres | 2021-01-12 SIR-Spheres microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns |