| Primary Device ID | 00191506068264 |
| NIH Device Record Key | 102f2d51-e053-4162-a54e-a8c137d14017 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TheraSphere 360™ |
| Version Model Number | M00139509001 |
| Catalog Number | M00139509001 |
| Company DUNS | 021717889 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506068264 [Primary] |
| LLZ | System, image processing, radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-16 |
| Device Publish Date | 2026-01-08 |
| 00191506068264 - TheraSphere 360™ | 2026-01-16Y-90 Management Platform |
| 00191506068264 - TheraSphere 360™ | 2026-01-16 Y-90 Management Platform |
| 08714729058410 - Contour VL™ | 2026-01-16 Variable Length Ureteral Stent |
| 08714729067986 - Contour VL™ | 2026-01-16 Variable Length Ureteral Stent |
| 08714729068020 - Contour VL™ | 2026-01-16 Variable Length Ureteral Stent |
| 08714729902959 - Percuflex™ Plus SureDrive™ | 2026-01-16 Steerable Ureteral Stent Set |
| 08714729902966 - Percuflex™ Plus SureDrive™ | 2026-01-16 Steerable Ureteral Stent Set |
| 08714729902973 - Percuflex™ Plus SureDrive™ | 2026-01-16 Steerable Ureteral Stent Set |
| 08714729902980 - Percuflex™ Plus SureDrive™ | 2026-01-16 Steerable Ureteral Stent Set |