| Primary Device ID | 08033945938826 |
| NIH Device Record Key | 6c0b4fed-359f-4c6a-ba2d-4ce201529b8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Single use Surgical Optical Fiber |
| Version Model Number | EMP-FBX200BHS-C |
| 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 | false |
| 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 | 08033945938543 [Primary] |
| GS1 | 08033945938680 [Package] Contains: 08033945938543 Package: carton box [5 Units] In Commercial Distribution |
| GS1 | 08033945938826 [Package] Contains: 08033945938680 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2018-09-28 |
| 08059173391202 | Single use ball-tip 272 micron Sterile Surgical Optical Fiber |
| 08059173392162 | Single use Surgical Optical Fiber Ø 150 µm |
| 08033945938826 | Single use Ball tip Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologi |
| 08033945938802 | Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945938741 | Single use ball-tip 272 micron Sterile Surgical Optical Fiber |
| 08033945938451 | Single use Surgical Optical Fiber ø 1000 µm. Distributed by Olympus Surgical Technologies Amer |
| 08033945938727 | Single use Surgical Optical Fiber ø 550µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945938710 | Single use Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies Ameri |
| 08033945938703 | Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945938697 | Single use Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945938390 | Single use ball-tip 272 micron Sterile Surgical Optical Fiber |
| 08033945938307 | Single use Ball tip Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologi |
| 08033945938246 | Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945938147 | Single use Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies Ameri |
| 08033945938086 | Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945937997 | Single use Surgical Ball tip Optical Fiber ø 272 µm. Distributed by Olympus Surgical Technolog |
| 08033945937935 | Single use Surgical Optical Fiber ø 1000 µm. Distributed by Olympus Surgical Technologies Amer |
| 08033945937812 | Single use Surgical Optical Fiber ø 550µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945937690 | Single use Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies Americ |
| 08033945937485 | Single Use Surgical Optical Fiber ø 800 µm Distributed by Cogentix. |
| 08033945937478 | Single Use Surgical Optical Fiber ø 550 µm Distributed by Cogentix. |
| 08033945937461 | Single Use Surgical Optical Fiber ø 365 µm Distributed by Cogentix. |
| 08033945937454 | Single Use Surgical Optical Fiber ø 272 µm Distributed by Cogentix. |
| 08033945937072 | Single use Surgical Optical Fiber ø 365 µm |
| 08033945937041 | Single use Surgical Optical Fiber ø 272µm |
| 08033945936754 | Single use Performance Surgical Optical Fiber Ø 365 µm |
| 08033945936747 | Single use Precision Surgical Optical Fiber ø 272µm |
| 08033945936730 | Single use Performance Surgical Optical Fiber Ø 365 µm |
| 08033945936723 | Single use Precision Surgical Optical Fiber ø 272µm |
| 08033945936716 | Single use Performance Surgical Optical Fiber ø 365 µm |
| 08033945936709 | Single use Precision Surgical Optical Fiber ø 272µm |
| 8033945936242 | Single use Surgical Optical Fiber Ø 1000 µm Manufactured for Edap Technomed Inc. |
| 8033945936235 | Single use Surgical Optical Fiber Ø 800 µm Manufactured for Edap Technomed Inc. |
| 8033945936228 | Single use Surgical Optical Fiber Ø 550 µm Manufactured for Edap Technomed Inc. |
| 8033945936211 | Single use Surgical Optical Fiber Ø 365 µm Manufactured for Edap Technomed Inc. |
| 08033945936020 | Single use Surgical Optical Fiber ø 272 µm Manufactured for Edap Technomed Inc. |
| 8033945936198 | Single use Surgical Optical Fiber ø 200µm Manufactured for Edap Technomed Inc. |
| 08033945934873 | Single use Surgical Optical Fiber ø 400 µm |
| 08033945934484 | Single use Surgical Optical Fiber Ø 272 µm |
| 08033945934453 | Single use Surgical Optical Fiber Ø 200 µm |
| 08033945934422 | Single use Surgical Optical Fiber Ø 1000 µm |
| 08033945934408 | Single use Surgical Optical Fiber Ø 800 µm |
| 08033945934378 | Single use Surgical Optical Fiber Ø 400 µm |
| 08033945933654 | Single use Surgical Optical Fiber Ø 1000 µm |
| 08033945933647 | Single use Surgical Optical Fiber Ø 800 µm |
| 08033945933630 | Single use Surgical Optical Fiber Ø 600 µm |
| 08033945933623 | Single use Surgical Optical Fiber Ø 550 µm |
| 08033945933616 | Single use Surgical Optical Fiber ø 365 µm |
| 08033945933609 | Single use Surgical Optical Fiber ø 272µm |
| 08033945933548 | Single use Surgical Optical Fiber Ø 1000 µm |