V. Mueller
V. Mueller WALTHER DILATOR-CATHETER FEMALE, MIRROR FINISH, 32FR. OVERALL LENGTH 5-3/4 inches 14.5CM
4manufacturers in China registered for this device type
14catalogue 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 | Steris Corporation, United States |
|---|---|
| FDA product code | KOE |
| Device type | Dilator, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-08-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GU4100-036 | In distribution | |
| GU4100-032 | In distribution | |
| GU4100-016 | In distribution | |
| GU4100-034 | In distribution | |
| GU4100-014 | In distribution | |
| GU4100-012 | In distribution | |
| GU4100-022 | In distribution | |
| GU4100-038 | In distribution | |
| GU4100-018 | In distribution | |
| GU4100-020 | In distribution | |
| GU4100-028 | In distribution | |
| GU4100-026 | In distribution | |
| GU4100-030 | In distribution | |
| GU4100-024 | In distribution |
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 |
| Dilator, Urethral | Richard Wolf Gmbh | 15 |
| 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.