gudid Primary ID: Cement gun

PALAMIX (UDI Cement gun)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The PALAMIX (Model/Catalog Number: Cement gun) is a medical device manufactured by Heraeus Medical GmbH. This product is indexed under FDA Product Code / Category Classification KIH within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Cement gun
Product Code / EMDN: KIH
Device Name: The PALAMIX cement gun is intended to accommodate the mixing cartridges of the PALAMIX vacuum mixing system or the PALACOS R+G pro and then to ensure precise and effortless application of bone cement. The trigger of the PALAMIX cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX cement gun can only be used in conjunction with the PALAMIX vacuum mixing system or PALACOS R+G pro.
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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Frequently Asked Questions

Who is the primary manufacturer of PALAMIX?

The registered manufacturer of record for PALAMIX is Heraeus Medical GmbH.

What is the Primary UDI-DI identifier for PALAMIX?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Cement gun.

What classification code is assigned to this device?

This device is registered under product classification code KIH.

Similar Classification Devices (KIH)

Other Devices by Heraeus Medical GmbH

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