The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a…
The Lithotomy Drape (see Figure 1) is a sterile single use device that serves as a sterile barrier for the patient and isolates the surgical site. The Lithotomy Drape also provides a sterile barrier between transurethral and rectal instruments, while also managing fluid collection. The Lithotomy Drape allows the physician to conduct an Aquablation® or other transurethral or transrectal urological procedures and reduce the risk of breaching sterility. The Lithotomy Drape, measuring 105 inches by 53 inches, is made of a Non-woven SMS textile, transparent poly sheeting, and a fluid pouch with a mesh screen.
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Lithotomy Drape | Listed by | Procept BioRobotics Corporation, United States |
| FDA product code | EYY |
| Device type | Drape, Urological, Disposable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-04-05 |
| Record revised | 2026-01-19 (version 6) |
Specifications
Specifications | MRI safety | MR Safe |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -18 to 60 °C |
| Packaging | Shipper box of 8, 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.