Dornier MedTech
Minnow Ureteral Catheter, 5Fr x 70cm Open Tip - Right
4manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
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 | Dornier Medtech America, Inc., United States |
|---|---|
| FDA product code | EYB |
| Device type | Catheter, Ureteral, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2020-02-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Minnow Ureteral Catheter, 5Fr x 70cm Open Tip – Right | In distribution | |
| Minnow Ureteral Catheter, 6Fr x 70cm Open Tip – Left | In distribution | |
| Minnow Ureteral Catheter, 5Fr x 70cm Open Tip – Left | In distribution | |
| Minnow Ureteral Catheter, 6Fr x 70cm Open Tip – Right | 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 |
|---|---|
| K191187 | 2019-09-18 |
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.