| Primary Device ID | 07290016746761 |
| NIH Device Record Key | e9468adf-9f03-4529-8c22-df6eea09d845 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Treatment Kit 2.0 |
| Version Model Number | GM00030 (US) |
| Catalog Number | GM00030 (US) |
| Company DUNS | 514612758 |
| Company Name | VIORA LTD |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 07290016746754 [Primary] |
| GS1 | 07290016746761 [Package] Contains: 07290016746754 Package: [20 Units] In Commercial Distribution |
| KZE | Injector, Fluid, Non-Electrically Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-07-31 |
| Device Publish Date | 2025-06-03 |
| 07290016746716 - Console | 2025-07-31 EnerJet Console |
| 07290016746723 - Applicator | 2025-07-31 EnerJet Applicator |
| 07290016746730 - Trolley | 2025-07-31 EnerJet Trolley |
| 07290016746747 - Disposable Delivery Nozzle | 2025-07-31 EnerJet Delivery Nozzle |
| 07290016746761 - Treatment Kit 2.0 | 2025-07-31EnerJet Treatment Kit |
| 07290016746761 - Treatment Kit 2.0 | 2025-07-31 EnerJet Treatment Kit |
| 07290016746440 - ST Single Use Tip | 2025-06-30 ST Single Use Tip |
| 07290016746495 - DermaFuse | 2025-05-29 DermaFuse console |
| 07290016746679 - Brush Single-Use Tip | 2025-05-29 Brush Single-Use Tip for use with Dermafuse |