| Primary Device ID | 00850071153255 |
| NIH Device Record Key | 180dea5a-d10a-46ab-81b5-9e3972ccc1ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonablate System |
| Version Model Number | 711-17000-0009 |
| Company DUNS | 101084143 |
| Company Name | FOCUS SURGERY INC |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00850071153255 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-01 |
| Device Publish Date | 2025-08-22 |
| 00850071153255 - Sonablate System | 2025-09-01 |
| 00850071153255 - Sonablate System | 2025-09-01 |
| 00850071153064 - Water Path Kit | 2024-12-17 |
| 00850071153071 - Sonablate Insertion Pack | 2024-12-17 |
| 00850071153088 - Water Path Kit | 2024-12-17 |
| 00850071153095 - Sonablate Insertion Pack | 2024-12-17 |
| 00868108000298 - Water Path Kit | 2024-12-17 |
| 00868108000205 - Water Path Kit | 2024-12-16 Water Path Kit for use with Sonablate HIFU system. |
| 00850071153101 - O-ring Applicator Tool | 2024-12-10 Sonablate HIFU O-ring Applicator Tool. This tool is intended to be included with the Sonablate Insertion Pack and Water Path Kit |