| Primary Device ID | 08059173395613 |
| NIH Device Record Key | 26023f1b-5096-4880-9879-8fd058ec1ad8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optical Fiber Reusable 10x |
| Version Model Number | UL800R |
| 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 | false |
| 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 | 08059173395606 [Primary] |
| GS1 | 08059173395613 [Package] Contains: 08059173395606 Package: Carton box [5 Units] In Commercial Distribution |
| GS1 | 08059173395620 [Package] Package: Carton box [2 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
[08059173395613]
Hydrogen Peroxide;Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-02 |
| Device Publish Date | 2022-12-22 |
| 08059173395644 | Reusable 10x optical fiber with 1000 um diameter |
| 08059173395613 | Reusable 10x optical fiber with 800 um diameter |
| 08059173395583 | Reusable 10x optical fiber with 550 um diameter |
| 08059173395552 | Reusable 10x optical fiber with 365 um diameter |
| 08059173395521 | Reusable 10x optical fiber with 272 um diameter |
| 08059173395491 | Reusable 10x optical fiber with 200 um diameter |