| Primary Device ID | 04049539072023 |
| NIH Device Record Key | 2e671a39-ef9c-48e2-9a84-cdd2f3772739 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESIGHT 500 |
| Version Model Number | 302721-9020-000 |
| Company DUNS | 342228620 |
| Company Name | Carl Zeiss Meditec AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049539072023 [Primary] |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-10 |
| Device Publish Date | 2023-03-31 |
| 04049471100143 - Treatment Pack (Size M) | 2024-02-19 single use accessory for ZEISS femtosecond lasers |
| 04049471100150 - Treatment Pack (Size L) | 2024-02-19 single use accessory for ZEISS femtosecond lasers |
| 04049471100167 - Treatment Pack (Type KP) | 2024-02-19 single use accessory for ZEISS femtosecond lasers |
| 04049471100136 - Treatment Pack (Size S) | 2024-02-16 single use accessory for ZEISS femtosecond lasers |
| 04049539101341 - EyeMag Smart | 2023-11-16 |
| 04049539101358 - EyeMag Pro S | 2023-11-16 |
| 04049539101365 - EyeMag Pro F | 2023-11-16 |
| 04049539064103 - PENTERO® 800 S | 2023-09-19 |