Swann Morton Ltd.
Knife/blade handle. A metal surgical instrument e.g. stainless steel or brass, designed to mount a compatible blade used for cutting or dissecting tissue.
4manufacturers in China registered for this device type
17catalogue 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 | Swann Morton, Ltd., United Kingdom |
|---|---|
| FDA product code | FZW |
| Device type | Expander, Surgical, Skin Graft |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2022-09-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 158MM SKIN GRAFT BLADES | 10 | In distribution | |
| BRAITHWAITE SKIN GRAFT HANDLE | In distribution | ||
| SGD STERILE BLADE | 20 | In distribution | |
| PARAGON STERILE SKIN GRAFT BLADES | 10 | In distribution | |
| STERILE DERMATOME 3 SEG | 10 | In distribution | |
| STERILE DERMATOME 1 SEG | 10 | In distribution | |
| WATSON SKIN GRAFT HANDLE | In distribution | ||
| STAINLESS STEEL SILVERS SKIN GRAFT HANDLE | In distribution | ||
| STERILE DERMATOME 2 SEG | 10 | In distribution | |
| COBBETT SKIN GRAFT HANDLE | In distribution | ||
| LEFT HANDED WATSON SKIN GRAFT HANDLE | In distribution | ||
| SILVERS SKIN GRAFT HANDLE | In distribution | ||
| SKIN GRAFT BLADES SG3 | 20 | In distribution | |
| SILVERS STERILE SKIN GRAFT BLADES | 10 | In distribution | |
| SET – WATSON HANDLE | Withdrawn | ||
| SET BRAITHWAITE HANDLE | Withdrawn | ||
| SET BRAITHWAITE HANDLE | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Dilator | KLS-Martin L.P. | 2 |
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.