| Primary Device ID | 04049471100167 |
| NIH Device Record Key | df0d8fd4-ff3b-4efc-97d3-39413966a964 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Treatment Pack (Type KP) |
| Version Model Number | 1016 |
| Company DUNS | 314594680 |
| Company Name | Carl Zeiss Meditec AG |
| Device Count | 10 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049471100167 [Unit of Use] |
| GS1 | 04049471110166 [Primary] |
| HQF | Laser, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2024-02-09 |
| 04049539066435 - TIVATO® 700 | 2025-01-30 |
| 04049539106018 - SMARTDRAPE | 2025-01-30 |
| 04049539106070 - INTRABEAM SMARTDRAPE | 2025-01-30 |
| 04049539106094 - SMARTDRAPE | 2025-01-30 |
| 04049539106889 - EyeMag Smart TTL | 2025-01-30 |
| 04049539106896 - EyeMag Classic | 2025-01-30 |
| 04049471095074 - MEL 90 | 2024-12-23 The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue ac |
| 04049471095111 - VISUMAX | 2024-12-23 The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in th |