Dermatome
Electric Dermatome Power Supply
6manufacturers in China registered for this device type
30catalogue numbers in this listing
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 | Zimmer Orthopaedic Surgical Products, United States |
|---|---|
| FDA product code | GFD |
| Device type | Dermatome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Premarket notification | Exempt |
| Record published | 2021-10-18 |
| Record revised | 2025-12-10 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 85 °C; Handling environment humidity 30 to 60 % RH |
| Packaging | Carton of 10, cas of 10, shelf carton of 10 |
| Sizes | Width 1 to 4 in |
| Distribution end date | 2026-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-8831-004-00 | In distribution | |
| 8870N400 | Width: 4 Inch | In distribution |
| 00882100604 | In distribution | |
| 00-8801-001-00 | In distribution | |
| 00-8802-015-00 | Width 1.5 in | In distribution |
| 88710100 | In distribution | |
| 8870N150 | Width: 1.5 Inch | In distribution |
| 8870N300 | Width: 3 Inch | In distribution |
| 00-8821-006-00 | In distribution | |
| 8870N200 | Width: 2 Inch | In distribution |
| 8870N100 | Width: 1 Inch | In distribution |
| 88700010 | In distribution | |
| 00-8851-002-02 | 3 Meter Length | In distribution |
| 00-8851-002-05 | 3 Meter Length | In distribution |
| 00-8851-002-04 | 3 Meter Length | In distribution |
| 00-8802-004-00 | Width 4 in | In distribution |
| 00-8802-001-00 | Width 1 in | In distribution |
| 00-8802-002-00 | Width 2 in | In distribution |
| 00-8802-003-00 | Width 3 in | In distribution |
| 00-8851-002-03 | 3 Meter Length | In distribution |
| 00-8801-003-00 | In distribution | |
| 00-8851-002-06 | 3 Meter Length | In distribution |
| 00-8800-000-10 | In distribution | |
| 88700500 | In distribution | |
| 02-8871-000-00 | In distribution | |
| 88700300 | In distribution | |
| 00-8821-001-00 | In distribution | |
| 00-8851-002-07 | 3 Meter Length | In distribution |
| 00-8831-006-00 | In distribution | |
| 00-8803-000-00 | 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 |
| 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 |
| Trophy Skin | Trophy Skin, Inc. | 3 |
Showing 12 of 61. All products under Dermatome
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Zimmer Surgical, Inc. | UDI-DI | 2025-11-24 | Class II | Process control | The devices may have a misaligned thickness control bar. | 839 units |
| Zimmer Surgical, Inc. | UDI-DI | 2023-09-05 | Class II | Process control | Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area | 11,985 boxes (119,850 blades) |
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.