Sonachill
GUDID 00868108000274
System used to regulate temperature and oxygen content of sterile water for a procedure.
FOCUS SURGERY INC
Ultrasonic hyperthermia system| Primary Device ID | 00868108000274 |
| NIH Device Record Key | 226ae912-8e3f-40a8-9ff6-27e2726417f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonachill |
| Version Model Number | 102-17000-0007 |
| 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 | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868108000274 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN150011
FDA Product Code
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-02 |
| Device Publish Date | 2016-09-28 |
Devices Manufactured by FOCUS SURGERY INC
| 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 |
| 00868108000281 - Sonablate Insertion Pack | 2024-12-10 A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit. |
Trademark Results [Sonachill]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONACHILL 76279004 not registered Dead/Abandoned |
Focus Surgery, Inc. 2001-07-02 |
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