Quadtrac
Quad Cutter
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (3), Shandong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HRT |
| Device type | Stripper, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-12 |
| Record revised | 2023-09-07 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72205610 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dakota Alif System | Precision Spine, Inc. | 53 |
| Millennium | Avalign Technologies, Inc. | 32 |
| Ambler Surgical | Ambler Surgical, LLC | 30 |
| Instrument | Signus Medizintechnik Gmbh | 29 |
| Stripper | KLS-Martin L.P. | 25 |
| Buxton BioMedical | Buxton Biomedical, Inc. | 24 |
| Boss Instruments | Boss Instruments, Ltd. | 18 |
| Surtex | Surtex Instruments Ltd | 16 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 14 |
| Avalign | Avalign Technologies, Inc. | 12 |
| Stripper, Surgical | Biomet Microfixation | 12 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 11 |
Showing 12 of 62. All products under Stripper, 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.