Integra® Padgett® Dermatomes
Integra® Padgett® Dermatomes Five inch Manual Dermatome (Drum and Stand Only), 5X8 Inch Size. (12.5 X 20 cm)(Large)
6manufacturers in China registered for this device type
62catalogue numbers in this listing
4recalls on this code
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 | Integra Lifesciences Corporation, United States |
|---|---|
| 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 | 2018-02-23 |
| Record revised | 2023-04-04 (version 6) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 35399106 | In distribution | ||
| 353971513 | In distribution | ||
| 3539259 | In distribution | ||
| 35399102 | In distribution | ||
| 3539701 | In distribution | ||
| 3539236 | In distribution | ||
| AP0001 | In distribution | ||
| 3539105 | 10 | In distribution | |
| 353971525 | In distribution | ||
| 35392664 | In distribution | ||
| 3539602 | 10 | In distribution | |
| 35399100 | In distribution | ||
| 3539900 | In distribution | ||
| 35396105 | In distribution | ||
| 3539600 | In distribution | ||
| 35399101 | In distribution | ||
| 35396104 | In distribution | ||
| 3539250230 | In distribution | ||
| 3539115 | In distribution | ||
| 35399104 | In distribution | ||
| 3539620 | In distribution | ||
| 3539256 | In distribution | ||
| 35396102 | In distribution | ||
| 3539252 | 10 | In distribution | |
| 3539106 | 10 | In distribution | |
| 3539118 | In distribution | ||
| 3539799 | 20-3/8″ Length x 9-1/2″ Width | In distribution | |
| 35399103 | In distribution | ||
| 35392554 | In distribution | ||
| 35392551 | In distribution | ||
| 35392550 | In distribution | ||
| 35392663 | In distribution | ||
| 3539600230 | In distribution | ||
| 35392661 | In distribution | ||
| 3539100BTA | In distribution | ||
| 3539401 | In distribution | ||
| 35396106 | In distribution | ||
| 35392662 | In distribution | ||
| 35391015 | In distribution | ||
| 3539235 | In distribution | ||
| 3539700 | In distribution | ||
| 35391005TA | In distribution | ||
| 3539250 | In distribution | ||
| 35396100 | In distribution | ||
| 35396101 | In distribution | ||
| 35392553 | In distribution | ||
| 3539702 | In distribution | ||
| 35392660 | In distribution | ||
| 3539117 | In distribution | ||
| 3539101 | In distribution | ||
| 35396103 | In distribution | ||
| 3539800 | In distribution | ||
| 3539237 | In distribution | ||
| 35399105 | In distribution | ||
| 3539240 | In distribution | ||
| 35392552 | In distribution | ||
| 3539100TA | Withdrawn | ||
| 3539118R | Withdrawn | ||
| 3539118B | Withdrawn | ||
| AP1184 | Withdrawn | ||
| 3539500 | Withdrawn | ||
| DP0003 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Trophy Skin | Trophy Skin, Inc. | 3 |
Showing 12 of 61. All products under Dermatome
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2020-08-04 | Class II | Mixed-up of materials/components | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. | 74 units | 2021-08-12 |
| 2020-08-04 | Class II | Mixed-up of materials/components | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. | 13 units | 2021-08-12 |
| 2020-08-04 | Class II | Mixed-up of materials/components | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. | 2 units | 2021-08-12 |
| 2011-03-11 | Not classified | Other | Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient. | 892 units were distributed in the U.S & 155 units were distr | 2012-04-17 |
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.