Identity
- Trade Name
- COPAL® G+V FDA UDI
- Generic Name
- Orthopaedic cement, antimicrobial FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1x40 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 5184267 FDA UDI
- Primary DI / UDI-DI
- 04260102139855 FDA UDI
- FDA Product Code
- MBB FDA UDI
- GMDN Term
- Orthopaedic cement, antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Orthopaedic cement, antimicrobial
Copal® G+v by Heraeus Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement, antimicrobial.
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- Unite Cement — OSTEOREMEDIES, LLC · Class II
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- BRAVO MV+G — G21 SRL · Class II
- Simplex — Howmedica Osteonics Corp. · Class II
- Cemex Genta HV — Tecres · Class II
- REFOBACIN® BONE CEMENT R — Biomet, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Heraeus Medical LLC
Sources (1)
- FDA UDI b2361948-d44e-4dae-a910-d64a793de7a0 34 fields · synced May 30, 2026