Integra® Padgett®
Integra® Padgett® Dermatomes Teflon Roller for Skin Graft Expander
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Henan (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Yafho BIO-Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 14 |
| Jiangsu MJD Medical Technology Co., Ltd. | Taizhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | FZW |
| Device type | Expander, Surgical, Skin Graft |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2023-05-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P173 | In distribution | |
| P172 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Swann Morton Ltd. | Swann Morton, Ltd. | 17 |
| Expander, Surgical, Skin Graft | Zimmer Orthopaedic Surgical Products | 9 |
| Mesh|Ex | Exsurco Medical, Inc. | 7 |
| Brennen Skin Graft Mesher | Stellen Medical, LLC | 6 |
| Aesculap | Aesculap AG | 5 |
| MT | Jiangsu MJD Medical Technology Co., Ltd. | 4 |
| Meshgraft™ | Zimmer Orthopaedic Surgical Products | 4 |
| MeshgraftTM II Tissue Expansion System | Zimmer Orthopaedic Surgical Products | 4 |
| Motiva® Inflatable Balloon | Establishment Labs S.A. | 3 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 3 |
| 4Med | 4 MED Ltd. | 3 |
| Arthrex® | Arthrex, Inc. | 3 |
Showing 12 of 24. All products under Expander, Surgical, Skin Graft
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.