Goben
Closed Wound Drainage System, Silicone Drainage Kit 100ml Bulb Reservoir, Flat Drain 10mm, with Perforation, Sterile
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
Record
| Listed by | Huzhou Junda Industry Co., Ltd., China |
|---|---|
| FDA product code | GBA |
| Device type | Catheter, Balloon Type |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, carton of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JD14-R490107 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Balloon Type | Karl Storz GmbH & Co. KG | 6 |
| Envision | Spinal Stabilization Technologies, Ltd | 2 |
| Rusch | Teleflex Medical LLC | 1 |
| CooperSurgical, Inc. | Coopersurgical, Inc. | 1 |
| Verify | Spineology Inc. | 1 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 1 |
| Pneumatic Inflator | Boston Scientific Corporation | 1 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 1 |
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.