gudid
Primary ID: 1x40
COPAL G+V (UDI 1x40)
Manufactured by Heraeus Medical GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for COPAL G+V - Primary ID 1x40
Device Regulatory Overview
The COPAL G+V (Model/Catalog Number: 1x40) is a medical device manufactured by Heraeus Medical GmbH. This product is indexed under FDA Product Code / Category Classification MBB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1x40
- Product Code / EMDN
- MBB
- 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.
- Database Sync Date
- 2026-08-09 09:17:36
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of COPAL G+V?
The registered manufacturer of record for COPAL G+V is Heraeus Medical GmbH.
What is the Primary UDI-DI identifier for COPAL G+V?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1x40.
What classification code is assigned to this device?
This device is registered under product classification code MBB.
Similar Classification Devices (MBB)
Other Devices by Heraeus Medical GmbH
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