Dilator
Micro, Smith, Graft
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 | KLS-Martin L.P., United States |
|---|---|
| FDA product code | FZW |
| Device type | Expander, Surgical, Skin Graft |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2024-08-23 (version 5) |
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 |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00-101-16-07 | 10 | In distribution | |
| 00-101-17-07 | 10 | Withdrawn |
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.