Instrument
29 catalogue numbers from Osteotome, listed by Signus Medizintechnik Gmbh, Germany, under Stripper, Surgical. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
29catalogue numbers in this listing
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 | Signus Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | HRT |
| Device type | Stripper, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-06-20 |
| Record revised | 2023-01-26 (version 3) |
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, manufacturing date |
| Storage | Storage environment temperature 0 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Osteotome | 12mm,280mm | In distribution |
| Shaver curved | 13mm | In distribution |
| Shaver curved | 15mm | In distribution |
| Rasp | 10mm | In distribution |
| Bone curette straight | 3mm | In distribution |
| Curette, rectangular upward angled | 6x380mm,10° | In distribution |
| Raspatory, Cobb | 19mm,440mm | In distribution |
| Rasp | 6mm | In distribution |
| Rasp | 10mm | In distribution |
| Shaver curved | 12mm | In distribution |
| Shaver curved | 8mm | In distribution |
| Ring curette curved | 7x380mm,45° | In distribution |
| Shaver curved | 14mm | In distribution |
| Ring curette curved | 7x380mm,45° | In distribution |
| Osteotome | 8mm,280mm | In distribution |
| Shaver curved | 9mm | In distribution |
| Bone curette angled | 6,5mm/410mm,30°,upwards | In distribution |
| Shaver curved | 11mm | In distribution |
| Rasp | 8mm,18mm | In distribution |
| Shaver curved | 10mm | In distribution |
| Rasp, rectangular | 6x380mm | In distribution |
| Rasp | 6mm | In distribution |
| Bone curette angled | 6,5mm | In distribution |
| Bone curette straight | 5×10,3mm | In distribution |
| Rasp, rectangular | In distribution | |
| Curette, rectangular upward angled | 10x360mm,20° | In distribution |
| Curette, ISJ large | 300mm | In distribution |
| Osteotome | 8mm | In distribution |
| Rasp | 2,5x8x18mm | 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 |
| 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 |
| Rabea | Signus Medizintechnik Gmbh | 10 |
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.