| Primary Device ID | 08059173396580 |
| NIH Device Record Key | b4773631-4be0-4255-a133-da23b8130459 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single Use CO2 Laser fiber |
| Version Model Number | HAF805001 |
| Company DUNS | 436045833 |
| Company Name | QUANTA SYSTEM SPA |
| 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 | 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 | 08059173396573 [Primary] |
| GS1 | 08059173396580 [Package] Contains: 08059173396573 Package: carton box [5 Units] In Commercial Distribution |
| GS1 | 08059173396597 [Package] Package: carto n box [2 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-03 |
| Device Publish Date | 2026-01-26 |
| 08059173396580 - Single Use CO2 Laser fiber | 2026-02-03 |
| 08059173396580 - Single Use CO2 Laser fiber | 2026-02-03 |
| 08059173396535 - Levanta Plus | 2025-12-05 |
| 08059173392186 - Litho EVO | 2025-10-07 |
| 08059173396375 - Echo | 2024-07-01 |
| 08033945936938 - Laserlith I-dust | 2024-05-23 Manufactured for Edap TMS |
| 08059173396474 - Karma | 2023-12-21 |
| 08059173396399 - Rosso | 2023-06-23 |
| 08059173396405 - Rosso | 2023-06-23 |