Dynamic Tissue Systems™
DynaCleft Unilateral
10manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Chinmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
Record
| Listed by | Southmedic, Inc., Canada |
|---|---|
| FDA product code | MKY |
| Device type | System, Skin Closure |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4320 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 15, pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DWS12 | 10 | In distribution | |
| DWS14 | 10 | In distribution | |
| DCX20 | 7 | In distribution | |
| DCX10 | 7 | In distribution | |
| DSX38 | 4 | In distribution | |
| DSX24 | 4 | In distribution | |
| DWC38 | 4 | In distribution | |
| DWC24 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TopClosure | I.V.T. Medical Ltd | 13 |
| Endure Industries | Endure Industries, Inc. | 9 |
| Dermaclose | Synovis Micro Companies Alliance | 6 |
| BandGrip® Micro-Anchor® Skin Closure | Bandgrip Inc. | 2 |
| Dialfix 18 | Dfix | 1 |
| Hemigard Interlock | Suturegard Medical, Inc. | 1 |
| Dialfix 11 | Dfix | 1 |
| Dialfix Plus 3 | Dfix | 1 |
| Dialfix 24 | Dfix | 1 |
| Suturegard® Interlock | Suturegard Medical, Inc. | 1 |
| Dialfix 15 | Dfix | 1 |
| Zip PreLoc 2 Wound Closure Device | Stryker GmbH | 1 |
Showing 12 of 16. All products under System, Skin Closure
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.