GEN2
Alexander-Farabeuf Costal Periosteotome 8 1/4"
9manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (2), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Surgix Medical LLC, United States |
|---|---|
| FDA product code | HWM |
| Device type | Osteotome |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-25 |
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 |
| Sizes | Length 5 to 15 in; width 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G2N81477 | Length 5 in | In distribution |
| G2N81430 | Length 9.75 in | In distribution |
| G2N81351 | Length 11 in | In distribution |
| G2N81475 | Length 5 in | In distribution |
| G2N81366 | Length 15 in | In distribution |
| G2N81562 | Length 5 in | In distribution |
| G2N81420 | Length 9.75 in | In distribution |
| G2N81634 | Length 9.25 in | In distribution |
| G2N81565 | Length 5 in | In distribution |
| G2G36918 | Length 6.5 in | In distribution |
| G2N81422 | Length 9.75 in | In distribution |
| G2N81362 | Length 15 in | In distribution |
| G2C62411 | Length 8.25 in | In distribution |
| G2N81640 | Length 9.25 in | In distribution |
| G2E901111 | In distribution | |
| G2G36072 | Length 6.25 in | In distribution |
| G2N81572 | Length 5 in | In distribution |
| G2N81431 | Length 9.75 in | In distribution |
| G2N81363 | Length 15 in | In distribution |
| G2N81474 | Length 5 in | In distribution |
| G2N81433 | Length 9.75 in | In distribution |
| G2N81476 | Length 5 in | In distribution |
| G2N81421 | Length 9.75 in | In distribution |
| G2N81432 | Length 9.75 in | In distribution |
| G2N81423 | Length 9.75 in | In distribution |
| G2N81355 | Length 11 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 300 |
| Life Instruments | Life Instrument Corp. | 283 |
| Osteotome | KLS-Martin L.P. | 262 |
| Boss Instruments | Boss Instruments, Ltd. | 249 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 243 |
| Innomed, Inc. | Innomed, Inc. | 241 |
| Ambler Surgical | Ambler Surgical, LLC | 226 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 225 |
| Novo Surgical | Novo Surgical, Inc. | 213 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 177 |
| Osteotome | Biomet Microfixation | 170 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 158 |
Showing 12 of 279. All products under Osteotome
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.