Fassier-Duval Telescopic IM System
Cutting Wheel FOR THE Female Component Cutter
10manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Jiangsu Taimedical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Orthopediatrics Canada ULC, Canada |
|---|---|
| FDA product code | HXZ |
| Device type | Cutter, Wire |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-07 |
| Record revised | 2025-05-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: keep at room temperature |
| Sizes | Lumen/inner diameter 1.98 to 3.95 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MC200-TUBE 56 | Lumen/Inner Diameter 3.55 mm | In distribution |
| MC200-TUBE 32 | Lumen/Inner Diameter 1.98 mm | In distribution |
| MC200-TUBE 40 | Lumen/Inner Diameter 2.48 mm | In distribution |
| MC200-HANDLE | In distribution | |
| FC-CUT100 | In distribution | |
| CK200 | In distribution | |
| MC200-TUBE 48 | Lumen/Inner Diameter 3.16 mm | In distribution |
| FC-JIG 100 | In distribution | |
| FC-DISC | In distribution | |
| MC200 | In distribution | |
| FC-WHL100 | In distribution | |
| MC200-TUBE 64 | Lumen/Inner Diameter 3.95 mm | In distribution |
| MC100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 56 |
| Ambler Surgical | Ambler Surgical, LLC | 44 |
| Millennium | Avalign Technologies, Inc. | 36 |
| V. Mueller | Steris Corporation | 32 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 31 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 31 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 29 |
| Orthomed | Ortho-MED, Inc. | 24 |
| Tecomet | Tecomet, Inc. | 24 |
| Cutter, Wire | Synthes Gmbh | 22 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 22 |
| Kmedic | Teleflex Medical LLC | 20 |
Showing 12 of 175. All products under Cutter, Wire
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.