Tecoflex
7.0 FR (2.3mm) X 22 cm LUBRI-FLEX OPEN TIP URETERAL STENT HYDROPHILIC COATED TECOFLEX
4manufacturers in China registered for this device type
92catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Shenzhen Trious Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | FAD |
| Device type | Stent, Ureteral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4620 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K913928 |
| Record published | 2015-10-24 |
| Record revised | 2024-09-02 (version 6) |
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 |
|---|---|---|
| 5554526 | In distribution | |
| 5554508 | In distribution | |
| 5001960 | In distribution | |
| 5618522 | In distribution | |
| 5554510 | In distribution | |
| 5608530 | In distribution | |
| 5557022 | In distribution | |
| 5618530 | In distribution | |
| 5607026 | In distribution | |
| 5604526 | In distribution | |
| 5604528 | In distribution | |
| 5614518 | In distribution | |
| 5608528 | In distribution | |
| 5616026 | In distribution | |
| 5604524 | In distribution | |
| 5618520 | In distribution | |
| 5616030 | In distribution | |
| 5614514 | In distribution | |
| 5604510 | In distribution | |
| 5614516 | In distribution | |
| 5618528 | In distribution | |
| 5604520 | In distribution | |
| 5604522 | In distribution | |
| 5614510 | In distribution | |
| 5616020 | In distribution | |
| 5556030 | In distribution | |
| 5614528 | In distribution | |
| 5554522 | In distribution | |
| 5554514 | In distribution | |
| 5608522 | In distribution | |
| 5617026 | In distribution | |
| 5616022 | In distribution | |
| 5617028 | In distribution | |
| 5616024 | In distribution | |
| 5614512 | In distribution | |
| 5558530 | In distribution | |
| 5558522 | In distribution | |
| 5607024 | In distribution | |
| 5614508 | In distribution | |
| 5604516 | In distribution | |
| 5554518 | In distribution | |
| 5557026 | In distribution | |
| 5554528 | In distribution | |
| 5608524 | In distribution | |
| 5557028 | In distribution | |
| 5617022 | In distribution | |
| 5608520 | In distribution | |
| 5604508 | In distribution | |
| 5617020 | In distribution | |
| 5608526 | In distribution | |
| 5614522 | In distribution | |
| 5554520 | In distribution | |
| 5616028 | In distribution | |
| 5556028 | In distribution | |
| 5558528 | In distribution | |
| 5557024 | In distribution | |
| 5476160 | In distribution | |
| 5606026 | In distribution | |
| 5476260 | In distribution | |
| 5554524 | In distribution | |
| 5556026 | In distribution | |
| 5001985 | In distribution | |
| 5558526 | In distribution | |
| 5607020 | In distribution | |
| 5607022 | In distribution | |
| 5554512 | In distribution | |
| 5476300 | In distribution | |
| 5606022 | In distribution | |
| 5001945 | In distribution | |
| 5607028 | In distribution | |
| 5556024 | In distribution | |
| 5614520 | In distribution | |
| 5554516 | In distribution | |
| 5556022 | In distribution | |
| 5614524 | In distribution | |
| 5606020 | In distribution | |
| 5604530 | In distribution | |
| 5606030 | In distribution | |
| 5558524 | In distribution | |
| 5614526 | In distribution | |
| 5607030 | In distribution | |
| 5617030 | In distribution | |
| 5614530 | In distribution | |
| 5618526 | In distribution | |
| 5606028 | In distribution | |
| 5604514 | In distribution | |
| 5606024 | In distribution | |
| 5604512 | In distribution | |
| 5617024 | In distribution | |
| 5618524 | In distribution | |
| 5604518 | In distribution | |
| 5001970 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Porges Coloplast | Coloplast A/S | 509 |
| Polaris™ Ultra | Boston Scientific Corporation | 406 |
| Universa | Cook Incorporated | 384 |
| Percuflex™ Plus | Boston Scientific Corporation | 300 |
| Polaris™ Loop | Boston Scientific Corporation | 232 |
| ImaJin | Coloplast A/S | 219 |
| Contour™ | Boston Scientific Corporation | 205 |
| Percuflex™ | Boston Scientific Corporation | 152 |
| Vortek | Coloplast A/S | 92 |
| Sof-Flex | Cook Incorporated | 60 |
| Tria™ Firm | Boston Scientific Corporation | 58 |
| Q Urological Persistent Aguamedicina | Q Urological Corporation | 44 |
Showing 12 of 131. All products under Stent, Ureteral
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.