gudid
Primary ID: hip S medium
COPAL exchange G (UDI hip S medium)
Manufactured by Heraeus Medical GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for COPAL exchange G - Primary ID hip S medium
Device Regulatory Overview
The COPAL exchange G (Model/Catalog Number: hip S medium) is a medical device manufactured by Heraeus Medical GmbH. This product is indexed under FDA Product Code / Category Classification KWY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- hip S medium
- Product Code / EMDN
- KWY
- Device Name
- COPAL exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL exchange G hip spacer is intended for single-use and is supplied sterile.COPAL exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
- 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 exchange G?
The registered manufacturer of record for COPAL exchange G is Heraeus Medical GmbH.
What is the Primary UDI-DI identifier for COPAL exchange G?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is hip S medium.
What classification code is assigned to this device?
This device is registered under product classification code KWY.
Similar Classification Devices (KWY)
Other Devices by Heraeus Medical GmbH
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