UroMax Ultra
11 catalogue numbers from M0062251080, listed by Boston Scientific Corporation, United States, under Dilator, Urethral. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | KOE |
| Device type | Dilator, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5520 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-08-12 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0062251080 | 18 F Diameter | In distribution |
| M0062251070 | 6 cm Effective Length | In distribution |
| M0062251160 | 15 F Diameter | In distribution |
| M0062251060 | 12 F Diameter | In distribution |
| M0062251050 | 30 F Diameter | In distribution |
| M0062251040 | 24 F Diameter | In distribution |
| M0062251180 | 10 cm Effective Length | In distribution |
| M0062251090 | 21 F Diameter | In distribution |
| M0062251010 | 15 F Diameter | In distribution |
| M0062251150 | 10 cm Effective Length | In distribution |
| M0062251100 | 24 F Diameter | 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 |
| V. Mueller | Steris Corporation | 14 |
| EZDilate | Gyrus Acmi, Inc. | 11 |
| QL Disposable Inflation Device | Atrion Medical Products, Inc. | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922349 | 1992-08-14 |
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.