UroSeal
The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the working channel of a ureteroscope or cystoscope.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | EYK |
| Device type | Connector, Ureteral Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5130 |
| Premarket notification | Exempt |
| Record published | 2022-11-28 |
| Record revised | 2024-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00913410 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 4 |
| Connector | Boston Scientific Corporation | 4 |
| Connector, Ureteral Catheter | Boston Scientific Corporation | 4 |
| GU Tek | V L V Associates (inc) | 1 |
| Sealing Connector Y piece | Wismed PL SP Z O O | 1 |
| Sealing Connector T piece | Wismed PL SP Z O O | 1 |
| Sealing Connector I Piece | Wismed PL SP Z O O | 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.