Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the…
Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for SurgiCube drape | Listed by | Toul Meditech AB, Sweden |
| FDA product code | HMT |
| Device type | Drape, Patient, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-10 |
| Record revised | 2021-06-22 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Cartong box of 42 |
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.