Oscar
Single Use 6mm Scraper Probe - Slim - 180mm – Sterile
6manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Orthosonics, Ltd., United Kingdom |
|---|---|
| FDA product code | JDX |
| Device type | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.4580 |
| Record published | 2017-07-10 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Sizes | Outer diameter 6 to 8 mm; length 180 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Length 180 mm | In distribution |
| 1 | Outer Diameter 8 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 |
| Oscar PRO | Orthofix SRL | 36 |
| Ultra-Drive® Tool | Biomet Orthopedics | 11 |
| Mectron | Mectron SPA | 11 |
| Satelec | Satelec | 1 |
| Ultra-Drive® | Biomet Orthopedics | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093805 | 2010-02-19 |
| K083830 | 2009-03-20 |
| K051053 | 2005-07-21 |
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.