COPAL® G+V 5184267

GUDID 04260102139862

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.

Heraeus Medical GmbH

Orthopaedic cement, antimicrobial

• Primary Device ID: 04260102139862
• NIH Device Record Key: b2361948-d44e-4dae-a910-d64a793de7a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COPAL® G+V
• Version Model Number: 1x40
• Catalog Number: 5184267
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102139855 [Primary]
GS1	04260102139862 [Package]; Contains: 04260102139855; Package: Carton [20 Units]; In Commercial Distribution
GS1	04260102139879 [Package]; Contains: 04260102139855; Package: Pallet [400 Units]; In Commercial Distribution

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-18
• Device Publish Date: 2024-06-10

Devices Manufactured by Heraeus Medical GmbH

• 04260102139862 - COPAL® G+V: 2024-06-18COPAL® 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.
• 04260102139862 - COPAL® G+V: 2024-06-18 COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed f
• 04260102136694 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136724 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136755 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136786 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136816 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136847 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected
• 04260102136878 - COPAL® exchange G: 2024-02-16 The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected