Acculan 3TI
Acculan 3Ti dermatome
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | GFD |
| Device type | Dermatome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-23 |
| Record revised | 2024-11-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GA670 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940208 | 1994-02-24 |
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.