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| 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 |
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| 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 | |
| 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
| 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) | 2021-08-24Dose 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) |
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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