Bonastent® Esophageal
12 catalogue numbers from BE-1810, listed by Sewoon Medical Co., Ltd., South Korea, under Prosthesis, Esophageal. 1 manufacturer in China is registered for this product code.
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Sewoon Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | ESW |
| Device type | Prosthesis, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3610 |
| Establishment | Contract manufacturer, Contract steriliser, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092144 |
| Record published | 2017-03-03 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BE-1810 | 100mm Stent Length | In distribution |
| BE-1816 | 160mm Stent Length | In distribution |
| BER-1808 | 80mm Stent Length | In distribution |
| BER-1806 | 60mm Stent Length | In distribution |
| BE-1806 | 60mm Stent Length | In distribution |
| BE-1814 | 140mm Stent Length | In distribution |
| BER-1810 | 100mm Stent Length | In distribution |
| BER-1814 | 140mm Stent Length | In distribution |
| BE-1812 | 120mm Stent Length | In distribution |
| BER-1816 | 160mm Stent Length | In distribution |
| BER-1812 | 120mm Stent Length | In distribution |
| BE-1808 | 80mm Stent Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hilzo Esophageal stents | BCM Co., Ltd. | 464 |
| Esophageal TTS Stent | Taewoongmedical.co., Ltd. | 144 |
| Hanarostent® Esophagus (CCC) | M.I.Tech Co Ltd | 44 |
| Hanarostent® Esophagus TTS(NCN) | M.I.Tech Co Ltd | 40 |
| Hanarostent® Esophagus TTS(CCC) | M.I.Tech Co Ltd | 40 |
| Niti-S Esophageal Stent | Taewoongmedical.co., Ltd. | 40 |
| Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 36 |
| Hanarostent® Esophagus Asymmetric (CCC) | M.I.Tech Co Ltd | 32 |
| Alimaxx-ES™ | Merit Medical Systems, Inc. | 27 |
| Hanarostent® Esophagus (NCN) | M.I.Tech Co Ltd | 24 |
| EndoMAXX® | Merit Medical Systems, Inc. | 24 |
| Agile™ Esophageal | Boston Scientific Corporation | 24 |
Showing 12 of 20. All products under Prosthesis, Esophageal
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.