Instrument, Cast Removal, Ac-Powered
2.5 inch (63.5mm) Titanium Nitrided Cast Cutter Blade
4manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Zhejiang Longyou Landmedical Technology Co., Ltd. | Longyou | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Zhengda Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | LGH |
| Device type | Instrument, Cast Removal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5960 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-23 |
| Record revised | 2024-04-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 40 °C; Storage environment humidity 10 to 75 % RH |
| Packaging | Pack of 12 |
| Sizes | Width 63.5 mm |
| Distribution end date | 2021-04-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0864011000 | In distribution | |
| 0986500000 | In distribution | |
| 0840023000 | Diameter: 63.5 Millimeter | Withdrawn |
| 0940025000 | Width 63.5 mm | Withdrawn |
| 0940035000 | Width 63.5 mm | Withdrawn |
| 0941000000 | Withdrawn | |
| 0940023000 | Width 63.5 mm | Withdrawn |
| 0840040250 | Diameter: 63.5 Millimeter | Withdrawn |
| 0840040350 | Diameter: 63.5 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| De Soutter Medical | DE Soutter Medical Ltd. | 108 |
| American Orthopaedic™ | BSN Medical, Inc. | 4 |
| CastVac | Stryker GmbH | 2 |
| Delta-Cast Serene | BSN Medical, Inc. | 2 |
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.