Dialfix 21
Dialfix 21: 1 catalogue number listed by Dfix, South Korea, under System, Skin Closure. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
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 | Dfix, South Korea |
|---|---|
| FDA product code | MKY |
| Device type | System, Skin Closure |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4320 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01 | Wound size 20 to 25cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TopClosure | I.V.T. Medical Ltd | 13 |
| Endure Industries | Endure Industries, Inc. | 9 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 8 |
| 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 |
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.