| Primary Device ID | 00868108000267 |
| NIH Device Record Key | 797987a4-3b25-4018-b9b6-84f334183c27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sonablate Insertion Pack |
| Version Model Number | 403-02200-0014 |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00868108000267 [Primary] |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-08 |
| Device Publish Date | 2017-03-24 |
| 00868108000274 - Sonachill | 2020-03-02 System used to regulate temperature and oxygen content of sterile water for a procedure. |
| 00868108000267 - Sonablate Insertion Pack | 2019-02-08A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit |
| 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 | 2018-03-29 Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy. |