SIR-Spheres® Microspheres Activity Calculator (SMAC)
GUDID 00850014612108
Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
SIRTEX MEDICAL PTY LTD
Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical information system web-based application software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software Clinical management support software| Primary Device ID | 00850014612108 |
| NIH Device Record Key | 6a8cf5b1-bfd7-40c7-b03e-3a3eb9998db9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIR-Spheres® Microspheres Activity Calculator (SMAC) |
| Version Model Number | X-SMAC-01 |
| Company DUNS | 755092467 |
| Company Name | SIRTEX MEDICAL PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| info-us@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| info-us@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| info-us@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| info-us@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@sirtex.com | |
| Phone | 1-888-474-7839 |
| info-us@sirtex.com | |
| Phone | 1-888-474-7839 |
| qa@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 | |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014612108 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202392
FDA Product Code
| KPS | System, Tomography, Computed, Emission |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-24 |
| Device Publish Date | 2021-08-16 |
Devices Manufactured by SIRTEX MEDICAL PTY LTD
| 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) | 2021-08-24Dose activity calculator for Selective Internal Radiation Therapy (SIRT) |
| 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) |
| 00850014612085 - SIR-Spheres Syringe Shield | 2021-07-19 SIR-Spheres Syringe Shield |
Trademark Results [SIR-Spheres]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIR-SPHERES 75438813 2646018 Live/Registered |
SIRTEX SIR-SPHERES PTY LTD 1998-02-23 |
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