| Primary Device ID | 04050555004202 |
| NIH Device Record Key | 90587687-49d8-4c02-b1aa-02b61d89c372 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TECHNOLAS TENEO 317 |
| Version Model Number | Model2 |
| Company DUNS | 341325716 |
| Company Name | Technolas Perfect Vision GmbH |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04050555004202 [Primary] |
| LZS | Excimer Laser 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 | 2023-12-25 |
| Device Publish Date | 2023-12-17 |
| 04050555002086 - Patient Interface 125 Kit | 2024-03-21 |
| 04050555004202 - TECHNOLAS TENEO 317 | 2023-12-25 |
| 04050555004202 - TECHNOLAS TENEO 317 | 2023-12-25 |
| 04050555000839 - MICROKERATOME Disposable Tubing | 2018-12-03 Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide |
| 04050555000976 - ACCUGLIDE® Disposable Blade | 2018-12-03 Disposable blades for HANSATOME® Microkeratome. |
| 04050555000983 - Zyoptix® XP Microkeratome Disposable Blades | 2018-12-03 Disposable blades for ZYOPTIX® XP Microkeratome. |
| 04050555000990 - Patient Interface 125 Kit | 2018-12-03 Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher). Kit consists of Patient Interf |
| 04050555002895 - VICTUS™ Femtosecond Laser Platform | 2018-12-03 The laser system is an ophthalmologic system based on femtosecond technology. It is used to treat a wide variety of ophthalmolog |
| 04050555004165 - VICTUS VERAFIT Patient Interface Kit | 2018-12-03 Patient Interface Kit for VICTUS™ Femtosecond Laser Platform (software version 2.7 and higher). Kit consists of Patient Interf |