| Primary Device ID | 04049539106070 |
| NIH Device Record Key | 62e06381-419d-4bbb-babe-4a0f88788ca3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRABEAM SMARTDRAPE |
| Version Model Number | 326091-0000-000 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049539106063 [Primary] |
| GS1 | 04049539106070 [Package] Contains: 04049539106063 Package: Secondary Package [5 Units] In Commercial Distribution |
| GS1 | 04049539106087 [Package] Package: Tertiary Package [6 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-30 |
| Device Publish Date | 2025-01-22 |
| 04049539066435 - TIVATO® 700 | 2025-01-30 |
| 04049539106018 - SMARTDRAPE | 2025-01-30 |
| 04049539106070 - INTRABEAM 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 |