7 Fr. Ureteral Catheter
The UroGen ureteral catheter provides retrograde access to the upper urinary tract for drainage or delivery of gels and fluids. It is placed by a physician using standard endoscopic…
The UroGen ureteral catheter provides retrograde access to the upper urinary tract for drainage or delivery of gels and fluids. It is placed by a physician using standard endoscopic techniques, with a guidewire when needed.
The catheter passes over a prepositioned guidewire up to 0.038 inches in diameter. A Luer lock bonded to the catheter body provides the proximal connection for fluid delivery. Typical placement lasts less than one hour.
Sterile Supply
The catheter is supplied sterile in a Tyvek pouch with a sterilization indicator and is intended for single use. It is a temporary access and delivery catheter for the specified urinary tract procedures.
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Urogen Pharma Ltd., Israel |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K180354 |
| Record published | 2019-02-11 |
| Record revised | 2020-04-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton box of 10 |
| Sizes | Catheter length 70 cm; catheter gauge 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Ureteral catheter | Catheter Length 70 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
Showing 12 of 150. All products under Catheter, Urological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211032 | 2021-11-19 |
| K180354 | 2018-10-30 |
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.