Copal® G+V
COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone.…
COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone. It contains the aminoglycoside antibiotic gentamicin and the glycopeptide antibiotic vancomycin to protect the cured bone cement and surrounding tissue from colonization by bacteria that are sensitive to gentamicin and/or vancomycin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex(E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. COPAL® G+V is intended for single-use and is supplied sterile.
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Heraeus Medical LLC, United States |
|---|---|
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2024-06-10 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 20, pallet of 400 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1×40 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remedy Spacer | Osteoremedies, LLC | 28 |
| CeMend Shoulder Spacer Mold | G21 SRL | 12 |
| Palacos® | Heraeus Medical LLC | 8 |
| StageOne™ | Biomet Orthopedics | 8 |
| SpaceFlex Shoulder | G21 SRL | 6 |
| Interspace Tapered Wedge Stem | Tecres SPA | 6 |
| InterSpace Hip | Tecres SPA | 6 |
| Surespace | Ortho Development Corp. | 5 |
| Prostalac | Depuy Orthopaedics, Inc. | 4 |
| CeMend Shoulder Spacer | G21 SRL | 4 |
| Rally | Smith & Nephew, Inc. | 3 |
| Smartset | Depuy (Ireland) | 3 |
Showing 12 of 44. All products under Bone Cement, Antibiotic
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.