Drape, Urological, Disposable

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shanghai and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. Jiangsu
Ningbo Jenius Polymer SCI-Tech Co., Ltd. Zhejiang
Shanghai Joy Crown Industry Co., Ltd. Shanghai, contract manufacturer

How Is EYY Classified?

Drape, Urological, Disposable is FDA product code EYY, Class 2, 21 CFR 878.4370.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Drape, Urological, Disposable

Aquablation Therapy®

Essential Drape Pack

Drape, Urological, Disposable

Essential Drape 1PK

Catalogue number DR2500, listed by Procept BioRobotics Corporation, United States, under Drape, Urological, Disposable. 3 manufacturers in China are registered for this product code.

Drape, Urological, Disposable

Lithotomy Drape

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…

Drape, Urological, Disposable