The Product is a single use sterile accessory kit for the ZEISS phaco and vitreoretinal systems and has been designed to direct balanced salt solution from irrigation source to the surgical…
The Product is a single use sterile accessory kit for the ZEISS phaco and vitreoretinal systems and has been designed to direct balanced salt solution from irrigation source to the surgical handpieces and to convey the materials removed from the eye to a reservoir during eye surgery on anterior and posterior segments of the human eye.
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Quattro Cassette | Listed by | Carl Zeiss Meditec Inc, United States |
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2022-04-25 |
| Record revised | 2024-01-31 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 8 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.