| Primary Device ID | 05060652910053 |
| NIH Device Record Key | 95002ada-aa6a-4b30-8b83-72c5f2e3b761 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | swiftPro System |
| Version Model Number | SWF-MIC01 |
| Catalog Number | SWF-MIC01 |
| Company DUNS | 211334261 |
| Company Name | EMBLATION LIMITED |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 05060652910053 [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 | 2023-12-12 |
| Device Publish Date | 2023-12-04 |
| 05060652910138 - swiftPro Battery Pack | 2024-07-04 The battery pack for the swiftPro Hand-held Microwave Generator |
| 05060652910145 - swiftPro Charging Dock | 2024-07-04 The swiftPro Charging dock |
| 05060652910152 - swiftPro Battery Power System | 2024-07-04 swiftPro Battery Power System |
| 05060652910053 - swiftPro System | 2023-12-12swiftPro System |
| 05060652910053 - swiftPro System | 2023-12-12 swiftPro System |
| 05060652910060 - swiftPro Hand-Held Microwave Generator | 2023-12-12 The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft t |
| 05060652910077 - swiftPro DC power adaptor | 2023-12-12 The swiftPro DC power adaptor is used to power the swiftPro hand-held generator |
| 05060652910084 - swiftPro Cradle | 2023-12-12 The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use. |
| 05060652910091 - swiftPro URT Applicator Tip | 2023-12-12 The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp |