Cardinal Health
Cysto Scope Drape W/Pouch BNS
3manufacturers in China registered for this device type
3catalogue numbers in this listing
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Ningbo Jenius Polymer SCI-Tech Co., Ltd. | Yinzhou District, Ningbo | Zhejiang | Manufacturer | 29 |
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | EYY |
| Device type | Drape, Urological, Disposable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-06-23 |
| Record revised | 2026-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2022-12-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 45020MNS | 5 | In distribution | |
| 45020MNS | 5 | Withdrawn | |
| 45211MNS | 20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Convertors | Cardinal Health 200, LLC | 20 |
| GentleCath Hydrophilic Kit | Wellspect Healthcare | 4 |
| SimPro™ Set | Wellspect Healthcare | 3 |
| Lithotomy Drape | Procept BioRobotics Corporation | 3 |
| Essential Drape 1PK | Procept BioRobotics Corporation | 1 |
| Aquablation Therapy® | Microtek Medical LLC | 1 |
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.