| Primary Device ID | 00859019006400 |
| NIH Device Record Key | ff807781-732f-47f0-ba97-d457ed92fe88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEATfx Cart |
| Version Model Number | FPRCH9010 |
| Catalog Number | FPRCH9010 |
| Company DUNS | 809529469 |
| Company Name | GALIL MEDICAL INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00859019006400 [Primary] |
| NEY | System, Ablation, Microwave And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-24 |
| Device Publish Date | 2020-08-14 |
| 07290104831171 - HEATfx 2.1 20cm Needle | 2020-11-09 Microwave ablation needle |
| 07290104831188 - HEATfx 2.1 15cm Needle | 2020-11-09 Microwave ablation needle |
| 00859019006936 - HEATfx Microwave Ablation System | 2020-10-02 Microwave ablation system console |
| 00859019006394 - HEATfx Microwave Ablation System | 2020-08-24 Microwave ablation system console |
| 00859019006400 - HEATfx Cart | 2020-08-24Microwave Ablation System Accessory |
| 00859019006400 - HEATfx Cart | 2020-08-24 Microwave Ablation System Accessory |
| 07290104831140 - HEATfx 2.1 20cm Needle | 2020-08-24 Microwave ablation needle |
| 07290104831157 - HEATfx 2.1 15cm Needle | 2020-08-24 Microwave ablation needle |
| 00859019006417 - ICEfx Cryoablation System | 2020-03-30 Cryoablation System |