Bonastent® Biliary
12 catalogue numbers from BB-100818, listed by Sewoon Medical Co., Ltd., South Korea, under Stents, Drains And Dilators For The Biliary Ducts. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Sewoon Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Contract steriliser, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140760 |
| Record published | 2017-03-03 |
| Record revised | 2022-04-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BB-100818 | 80mm Stent Length | In distribution |
| BB-080918 | 90mm Stent Length | In distribution |
| BB-100718 | 70mm Stent Length | In distribution |
| BB-080718 | 70mm Stent Length | In distribution |
| BB-080618 | 60mm Stent Length | In distribution |
| BB-081018 | 100mm Stent Length | In distribution |
| BB-100918 | 90mm Stent Length | In distribution |
| BB-101018 | 100mm Stent Length | In distribution |
| BB-080518 | 50mm Stent Length | In distribution |
| BB-100618 | 60mm Stent Length | In distribution |
| BB-100518 | 50mm Stent Length | In distribution |
| BB-080818 | 80mm Stent Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
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.