Dermaclose
DERMACLOSE is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate wounds. After initial use, the device does not require added tightening. Depending…
DERMACLOSE is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate wounds. After initial use, the device does not require added tightening. Depending on the location and size of the wound, one or more DERMACLOSE may be used for hours – days providing tissue expansion. After expansion, remove device and suture or staple the wound closed
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 | Synovis Micro Companies Alliance, United States |
|---|---|
| FDA product code | MKY |
| Device type | System, Skin Closure |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4320 |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| 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, manufacturing date |
| Sizes | Length 66 to 95.25 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 580122000011 | In distribution | |
| GEM204020-K | In distribution | |
| GEM204010-K | Length 66 cm | In distribution |
| GEM204010-K | In distribution | |
| 580111000011 | In distribution | |
| GEM204020-K | Length 95.25 cm | 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 |
| 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.