CooperSurgical, Inc.
Adult Esophageal Balloon Catheter Set; PTFE Coated Stylet; 5 French
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | GBA |
| Device type | Catheter, Balloon Type |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2024-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-9005 | 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 |
| Verify | Spineology Inc. | 1 |
| Custom Medical Specialties, Inc. | Custom Assemblies, Inc. | 1 |
| Pneumatic Inflator | Boston Scientific Corporation | 1 |
| Goben | Huzhou Junda Industry Co., Ltd. | 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.