Oscar PRO
Oscar PRO Titanium Curved Blade Serrated L80MM W4MM Sterile
6manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Smtp Medical Co., Ltd. | Daxing District | Beijing | Manufacturer | 2 |
| Huaan Hengyi (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Shenzhen Codyson Electrical Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | JDX |
| Device type | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4580 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-06-10 |
| Record revised | 2025-10-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 80 to 459 mm; outer diameter 6 to 10 mm; width 4 to 19 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 99-O4OL18B10 | Length 180 mm | In distribution |
| 1 | Length 270 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 270 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 270 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 180 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 270 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 80 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 180 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 270 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 90 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 459 mm | In distribution |
| 1 | Length 90 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acteon | Satelec | 95 |
| Tors | Radley Scientific Ltd | 76 |
| Smtp | Smtp Medical Co., Ltd. | 48 |
| Ultra-Drive® Tool | Biomet Orthopedics | 11 |
| Mectron | Mectron SPA | 11 |
| Oscar | Orthosonics, Ltd. | 2 |
| Satelec | Satelec | 1 |
| Ultra-Drive® | Biomet Orthopedics | 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.