BonOs® R Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which,…
BonOs® R Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® R Genta cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R Genta does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
Who Else Makes It
Registered in Shanghai.
Record
Regulatory record for BonOs R Genta 1×40 | Listed by | Osartis Gmbh, Germany |
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2015-09-25 |
| Record revised | 2020-06-19 (version 4) |
Specifications
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 |
| Storage | Special storage condition: Store between 0°C (32°F) and 25°C (77°F); Handling environment temperature 17 to 25 °C |
| Packaging | Shipping unit of 20 |
| Sizes | Weight 40.8 g |
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.