Aesculap
Dermatome Spare Blade (43 mm), sterile, package of 10 pieces
6manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | 2020-05-08 |
| Record revised | 2021-06-22 (version 3) |
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 |
| Distribution end date | 2021-04-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BA715R | In distribution | ||
| BA713R | In distribution | ||
| GB228R | 10 | In distribution | |
| BA716SU | 10 | In distribution | |
| GB317 | 10 | Withdrawn | |
| GB313 | 10 | Withdrawn | |
| GB321 | 10 | Withdrawn |
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 |
| 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
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.