ProDriver Battery Pack, Single
Catalogue number PDBP-001-2, listed by Pro-Dex Inc, United States, under Screwdriver, Skullplate. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Pro-Dex Inc, United States |
|---|---|
| FDA product code | GXL |
| Device type | Screwdriver, Skullplate |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4900 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-29 |
| Record revised | 2024-12-19 (version 5) |
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, manufacturing date |
| Packaging | Case of 40, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PDBP-001-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 6 |
| Surgical Instrument | Jeil Medical Corporation | 4 |
| Screwdriver, Skullplate | Synthes Gmbh | 2 |
| Disposable Screwdriver Blade | Kontour (Xi’an) Medical Technology Co., Ltd. | 2 |
| Neuro Plating System | Osteonic Co., Ltd. | 2 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 2 |
| Hex Screwdriver Ball-End (2.5 MM) | Brainlab SE | 1 |
| Seeg Long Bolt Driver | Biomet Microfixation | 1 |
| Skull Reference Screwdriver Handle | Brainlab SE | 1 |
| Seeg Short Bolt Driver | Biomet Microfixation | 1 |
| Skull Reference Screwdriver Blade | Brainlab SE | 1 |
| Screwdriver | Neurovention, LLC | 1 |
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.