Duraglide
Duraglide Stone Balloon (Above), 11.5 MM X 200 CM
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 | ConMed Corporation, United States |
|---|---|
| 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K993892 |
| Record published | 2015-10-24 |
| Record revised | 2020-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 8.5 to 15 mm |
| Distribution end date | 2020-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 007143 | Outer Diameter 8.5 mm | In distribution |
| 007124 | Outer Diameter 11.5 mm | In distribution |
| 007123 | Outer Diameter 8.5 mm | In distribution |
| 007145 | Outer Diameter 15 mm | In distribution |
| 007125 | Outer Diameter 15 mm | In distribution |
| 007144 | Outer Diameter 11.5 mm | In distribution |
| 007125 | Outer Diameter 15 mm | Withdrawn |
| 007145 | Outer Diameter 15 mm | Withdrawn |
| 007123 | Outer Diameter 8.5 mm | Withdrawn |
| 007144 | Outer Diameter 11.5 mm | Withdrawn |
| 007124 | Outer Diameter 11.5 mm | Withdrawn |
| 007143 | Outer Diameter 8.5 mm | Withdrawn |
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.