Operace
Sterile singel-use trials. Identify the size of the sterile screwdriver insert
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (4), Shandong (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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Hangzhou Ruihao Medical Technology Ltd | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
Record
| Listed by | PB Swiss Tools AG, Switzerland |
|---|---|
| FDA product code | HXB |
| Device type | Probe |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80296 | In distribution | |
| 80295 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 219 |
| Probe | Depuy Spine, Inc. | 190 |
| Probe | Zimmer Trabecular Metal Technology, Inc. | 154 |
| Sklar® | Sklar Corporation | 136 |
| General Instruments | Alphatec Spine, Inc. | 112 |
| Life Instruments | Life Instrument Corp. | 107 |
| Tecomet | Tecomet, Inc. | 97 |
| Tetris ST | Signus Medizintechnik Gmbh | 65 |
| Invictus | Alphatec Spine, Inc. | 64 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 56 |
| Probe | Synthes Gmbh | 47 |
| Tasmin R | Signus Medizintechnik Gmbh | 47 |
Showing 12 of 330. All products under Probe
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.