Bard® Polyurethane Ureteral Catheters, Cone Tip
3 catalogue numbers from 138012, listed by C.R. Bard, Inc., United States, under Catheter, Ureteral, Gastro-Urology. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
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 | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | EYB |
| Device type | Catheter, Ureteral, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-23 |
| Record revised | 2019-02-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter gauge 5 to 6 Fr; length 70 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 138012 | Catheter Gauge 6 Fr | 10 | In distribution |
| 138010 | Length 70 cm | 10 | In distribution |
| 138008 | Length 70 cm | 10 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032521 | 2003-11-14 |
| K950300 | 1995-04-27 |
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.