Medline
SET,IRRIGATION,CYSTO/TUR,90,SINGLE Spike
8manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | LJH |
| Device type | System, Irrigation, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Record published | 2016-10-14 |
| Record revised | 2022-06-10 (version 3) |
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 |
| Storage | Special storage condition: Store at room temperature. |
| Packaging | Pack of 20, case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND19140 | In distribution | |
| DYND19124 | In distribution | |
| DYND19120 | In distribution | |
| DYND19144 | In distribution | |
| DYND19142 | In distribution | |
| DYND19122 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Irrigation Set | B. Braun Medical Inc. | 11 |
| MED-RX | Canadian Hospital Specialties Ltd. | 3 |
| AMSure ® Four Lead Bladder Irrigation Set | Amsino Medical Inc. | 2 |
| Asurys™ | Boston Scientific Corporation | 2 |
| AMSure® Cystoscopy/Bladder Irrigation Set | Amsino Medical Inc. | 2 |
| Arthromatic/Uromatic | Baxter Healthcare Corporation | 1 |
| Flo-Assist II | Northgate Technologies Inc. | 1 |
| Centurion | Centurion Medical Products Corporation | 1 |
| Avid TruCustom | Avid Medical, Inc. | 1 |
| Equimat | Karl Storz GmbH & Co. KG | 1 |
| System, Irrigation, Urological | Karl Storz GmbH & Co. KG | 1 |
| AMSure® TUR/Bladder Irrigation Set Y-Type | Amsino Medical Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970946 | 1997-06-10 |
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.