Catheter, Ureteral, Gastro-Urology
CONICAL IRRIGATION ADAPTOR Ø 3MM to connect a two-way tap or stopcock, female, reusable
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Shanghai (1). 2 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 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | EYB |
| Device type | Catheter, Ureteral, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-28 |
| Record revised | 2024-11-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization, Hydrogen Peroxide |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 3 mm; lumen/inner diameter 4 mm |
| Distribution end date | 2018-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 88000 | Outer Diameter 3 mm | Withdrawn |
| 88312 | Lumen/Inner Diameter 4 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coloplast | Coloplast A/S | 60 |
| Porges Coloplast | Coloplast A/S | 32 |
| Bard® Woven Ureteral Catheter | C.R. Bard, Inc. | 31 |
| Pigtail | Cook Incorporated | 18 |
| Sof-Flex | Cook Incorporated | 11 |
| AMSure® Red Rubber Urethral Catheter | Amsino Medical Inc. | 11 |
| Medline | Medline Industries, Inc. | 11 |
| Red Rubber Urethral Catheters | Dynarex Corp. | 9 |
| Bard® Polyurethane Ureteral Catheters, Open Tip | C.R. Bard, Inc. | 9 |
| TruCath | HR Pharmaceuticals Inc. | 8 |
| Cook | Cook Incorporated | 4 |
| Flexi-Tip | Cook Incorporated | 4 |
Showing 12 of 38. All products under Catheter, Ureteral, Gastro-Urology
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.