| Primary Device ID | 08059173392551 |
| NIH Device Record Key | 05870e67-f3c7-49a9-b78c-61d7f0d8708b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optical Fiber Single Use |
| Version Model Number | FSI150 |
| 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 | 08059173392346 [Primary] |
| GS1 | 08059173392551 [Package] Contains: 08059173392346 Package: Carton box [5 Units] In Commercial Distribution |
| GS1 | 08059173392766 [Package] Package: Carton 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 | 2022-05-20 |
| Device Publish Date | 2022-05-12 |
| 08059173392551 | Single use optical fiber Ø 150 µm |
| 08059173393817 | Single use optical fiber with 150 um diameter |
| 08059173394449 | Single use ball-tip optical fiber with 272 um diameter |
| 08059173393893 | Single use optical fiber with 272 um diameter |
| 08059173393879 | Single use Ball-tip optical fiber with 272 um diameter |
| 08059173393848 | Single use optical fiber with 200 um diameter |