Bioseal Inc.
Button Polyester 9/16" - 14mm
3manufacturers in China registered for this device type
20catalogue 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 | Bioseal, United States |
|---|---|
| FDA product code | KGS |
| Device type | Retention Device, Suture |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4930 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 20, case of 25, case of 50, case of 100, case of 30, case of 3 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19980/25 | In distribution | |
| 19986/50 | In distribution | |
| 19981/20 | In distribution | |
| 19973/20 | In distribution | |
| 19241/20 | In distribution | |
| 19234/50 | In distribution | |
| 19931/50 | In distribution | |
| 19975/25 | In distribution | |
| 19987/20 | In distribution | |
| 19449/50 | In distribution | |
| 19971/20 | In distribution | |
| 19989/25 | In distribution | |
| 19974/20 | In distribution | |
| 19972/50 | In distribution | |
| 19978/25 | In distribution | |
| 19983/20 | In distribution | |
| 19468/50 | In distribution | |
| 19239/30 | In distribution | |
| 19976/25 | In distribution | |
| 19973 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Stent Buttons | Boston Medical Products, 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.