Gyrus Acmi
CLASSIC Open Tip Ureteral Stent 8.5 FR X 22 cm w/PTFE Coated Moveable Core Guidewire .038” X 150 cm
4manufacturers in China registered for this device type
19catalogue 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) | K930733 |
| Record published | 2016-10-03 |
| Record revised | 2024-09-02 (version 7) |
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 |
| Distribution end date | 2017-06-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5387220 | In distribution | |
| 5316000 | In distribution | |
| 5316500 | In distribution | |
| 5627024 | Withdrawn | |
| 5607018 | Withdrawn | |
| 5388280 | Withdrawn | |
| 5477300 | Withdrawn | |
| 5326000 | Withdrawn | |
| 5626022 | Withdrawn | |
| 5388260 | Withdrawn | |
| 5386280 | Withdrawn | |
| 5327000 | Withdrawn | |
| 5387280 | Withdrawn | |
| 5637014 | Withdrawn | |
| 5388220 | Withdrawn | |
| 5387260 | Withdrawn | |
| 5388240 | Withdrawn | |
| 5386240 | Withdrawn | |
| 5627022 | Withdrawn |
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 |
| Tecoflex | Gyrus Acmi, Inc. | 92 |
| Vortek | Coloplast A/S | 92 |
| Sof-Flex | Cook Incorporated | 60 |
| Tria™ Firm | Boston Scientific Corporation | 58 |
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.