| Primary Device ID | 08052286590173 |
| NIH Device Record Key | 0d93beaa-edf2-4213-abc7-378d2e3e7a7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Echolaser Smart Interface (ESI) |
| Version Model Number | EI KT0 0005 521 |
| Company DUNS | 895683282 |
| Company Name | ELESTA SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08052286590173 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-28 |
| Device Publish Date | 2021-06-19 |
| 08052286590210 - Laser Thermal Therapy Kit S E | 2023-11-14 The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LAS |
| 08052286590227 - Laser Thermal Therapy Kit L E | 2023-11-14 The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LAS |
| 08052286590159 - INTRODUCER | 2021-06-28 CHIBA introducer needle, 21Gx11.7 cm |
| 08052286590166 - INTRODUCER | 2021-06-28 CHIBA introducer needle, 21Gx20.7 cm |
| 08052286590173 - Echolaser Smart Interface (ESI) | 2021-06-28Echolaser Smart Interface (ESI) and its accessories |
| 08052286590173 - Echolaser Smart Interface (ESI) | 2021-06-28 Echolaser Smart Interface (ESI) and its accessories |