2-Inch ASD Excision Ring Blade
Amalgatome SD Surgical Skin Grafting and Debridement Blade
6manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Guangdong (4), Shandong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Jiangsu MJD Medical Technology Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 4 |
| Shenzhen Xiaobaimaijia Networktechnology Co., Ltd. | Shen Zhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Exsurco Medical, Inc., United States |
|---|---|
| FDA product code | GFD |
| Device type | Dermatome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-18 |
| Record revised | 2021-06-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 30 to 70 % RH |
| Sizes | Outer diameter 2 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| X101789 | Outer Diameter 2 in | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Padgett® Dermatomes | Integra Lifesciences Corporation | 62 |
| MT | Jiangsu MJD Medical Technology Co., Ltd. | 38 |
| Dermatome | Zimmer Orthopaedic Surgical Products | 30 |
| Integra® Padgett® | Integra Lifesciences Corporation | 12 |
| Surtex | Surtex Instruments Ltd | 8 |
| De Soutter Medical | DE Soutter Medical Ltd. | 7 |
| Aesculap | Aesculap AG | 7 |
| Cellutome™ | KCI USA, Inc. | 6 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Epitech | Tara Medical Devices LLC | 4 |
| Tissue Bank Dermatome | Zimmer Orthopaedic Surgical Products | 4 |
| Inka | The Trustee for Kaiser Family Trust | 4 |
Showing 12 of 61. All products under Dermatome
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-04-17 | Class II | Use error | Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst. | 70 coaxial hoses | 2020-06-15 |
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.