Sonablate
GUDID 00868108000229
Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.
FOCUS SURGERY INC
Ultrasonic hyperthermia system| Primary Device ID | 00868108000229 |
| NIH Device Record Key | 028284e2-f7fc-49e7-8375-857cec7c94e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonablate |
| Version Model Number | 202-17000-0012 |
| 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 | 00868108000229 [Primary] |
FDA Product Code
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00868108000229]
High-level Disinfectant;Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-24 |
Devices Manufactured by FOCUS SURGERY INC
| 00868108000274 - Sonachill | 2020-03-02 System used to regulate temperature and oxygen content of sterile water for a procedure. |
| 00868108000267 - Sonablate Insertion Pack | 2019-02-08 A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit |
| 00868108000212 - Sonasource | 2018-03-29 Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control Sona |
| 00868108000229 - Sonablate | 2018-03-29Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy. |
| 00868108000229 - Sonablate | 2018-03-29 Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy. |
Trademark Results [Sonablate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONABLATE 77239670 3552645 Live/Registered |
THS International, Inc. 2007-07-26 |
 SONABLATE 75775384 2532689 Dead/Cancelled |
Focus Surgery 1999-09-09 |
 SONABLATE 74390697 not registered Dead/Abandoned |
DIASONICS, INC. 1993-05-14 |
 SONABLATE 74223406 not registered Dead/Abandoned |
DIASONICS, INC. 1991-11-18 |
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