Swann Morton Ltd.
A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade…
A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
Showing 12 of 17. All 17 manufacturers in China registered for Cutter, Surgical
Record
| Listed by | Swann Morton, Ltd., United Kingdom |
|---|---|
| FDA product code | FZT |
| Device type | Cutter, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-06 |
| Record revised | 2022-05-16 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BULK No. 3 STAINLESS STITCH CUTTERS | 500 | In distribution | |
| STITCH CUTTER STERILE RETRACTABLE SCALPELS | 10 | In distribution | |
| CMI BULK No. 3 STAINLESS STITCH CUTTERS (BRAND) | 500 | In distribution | |
| LONG STITCH CUTTERS | 100 | In distribution | |
| SHORT STITCH CUTTERS | 100 | In distribution | |
| STITCH CUTTER STERILE RETRACTABLE SCALPEL | 25 | In distribution | |
| STITCH CUTTER NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 500 | In distribution | |
| STITCH CUTTER STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| MIDI STITCH CUTTERS | 100 | In distribution | |
| STITCH CUTTER SURGICAL No. 3 FITMENT STAINLESS STERILE | 100 | In distribution | |
| LANCE STITCH CUTTERS | 100 | In distribution | |
| PARAGON STITCH CUTTER | 100 | In distribution | |
| STITCH CUTTER BULK NON STERILE RETRACTABLE SCALPELS | 500 | In distribution | |
| PARAGON STITCH CUTTER STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD | 10 | In distribution | |
| STITCH CUTTER STERILE DISPOSABLE SCALPELS | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 326 |
| Sklar® | Sklar Corporation | 93 |
| Tecomet | Tecomet, Inc. | 89 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 46 |
| Aesculap | Aesculap AG | 38 |
| Orthomed | Ortho-MED, Inc. | 37 |
| Surtex | Surtex Instruments Ltd | 35 |
| SeaSpine Spacer System – Pacifica | Seaspine Orthopedics Corporation | 24 |
| Millennium | Avalign Technologies, Inc. | 23 |
| Cutter, Surgical | Medtronic Sofamor Danek, Inc. | 22 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 22 |
| Velofix™ PEEK Lumbar Cage | CG MedTech Co., Ltd. | 20 |
Showing 12 of 177. All products under Cutter, Surgical
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.