Stent Buttons
2 catalogue numbers from 323011, listed by Boston Medical Products, Inc., United States, under Retention Device, Suture. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Boston Medical Products, Inc., United States |
|---|---|
| FDA product code | KGS |
| Device type | Retention Device, Suture |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4930 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-29 |
| Record revised | 2022-08-30 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 323011 | In distribution | |
| 323011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 20 |
| Xtendobutton | Smith & Nephew, Inc. | 7 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 4 |
| Retention Device, Suture | Smith & Nephew, Inc. | 2 |
| Vive | Vive Health LLC | 2 |
| Perchik | AngioDynamics, Inc. | 2 |
| FlowStasis | Inari Medical, Inc. | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Slip-Not® | Merit Medical Systems, Inc. | 2 |
| Poly Suture Button | Biomet Sports Medicine | 2 |
| StarGuard Suture Retention Plates – 9″ | Preservation Solutions, Inc. | 1 |
Showing 12 of 29. All products under Retention Device, Suture
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.