Dilator, Urethral
TELESCOPE DILATOR 18FR for nephrostomy, in particular for dilating transcutaneous punctures, TL 230 mm, reusable
4manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Seplou (Zhuhai) Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | KOE |
| Device type | Dilator, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-02-28 |
| Record revised | 2024-11-21 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C |
| Sizes | Outer diameter 3 to 10 mm; lumen/inner diameter 4 to 5 mm; length 84 to 119 mm |
| Distribution end date | 2025-01-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8968015 | Lumen/Inner Diameter 5 mm | In distribution |
| 896219 | Outer Diameter 3 mm | In distribution |
| 8968012 | Lumen/Inner Diameter 4 mm | In distribution |
| 8955308 | Outer Diameter 10 mm | In distribution |
| 895527 | Withdrawn | |
| 895506 | Withdrawn | |
| 859201 | Length 84 mm | Withdrawn |
| 8955181 | Outer Diameter 6 mm | Withdrawn |
| 8955151 | Outer Diameter 5 mm | Withdrawn |
| 859202 | Length 119 mm | Withdrawn |
| 8955211 | Outer Diameter 7 mm | Withdrawn |
| 8955241 | Outer Diameter 8 mm | Withdrawn |
| 8955271 | Outer Diameter 9 mm | Withdrawn |
| 8955121 | Outer Diameter 4 mm | Withdrawn |
| 8955091 | Outer Diameter 3 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 96 |
| Amplatz | Cook Incorporated | 66 |
| Wellead Urethral Dilator | Well Lead Medical Co., Ltd. | 17 |
| UroMax Ultra Kit | Boston Scientific Corporation | 16 |
| Peel-Away | Cook Incorporated | 15 |
| V. Mueller | Steris Corporation | 14 |
| EZDilate | Gyrus Acmi, Inc. | 11 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 11 |
| UroMax Ultra | Boston Scientific Corporation | 11 |
| Flexor | Cook Incorporated | 10 |
| Seplou | Seplou (Zhuhai) Co., Ltd. | 6 |
| Optilume Basic Urological Dilation catheter | Urotronic Inc | 6 |
Showing 12 of 49. All products under Dilator, Urethral
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.