PALAMIX® 66036163

GUDID 04260102131170

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.

Heraeus Medical GmbH

Orthopaedic cement dispenser

• Primary Device ID: 04260102131170
• NIH Device Record Key: 9b0f28f7-67df-4c0f-94a9-5fd93cfd67e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALAMIX®
• Version Model Number: Cement gun
• Catalog Number: 66036163
• Company DUNS: 333623937
• Company Name: Heraeus Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102131170 [Primary]

FDA Product Code

• KIH: Dispenser, Cement

Sterilization

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

[04260102131170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-13
• Device Publish Date: 2018-03-19

On-Brand Devices [PALAMIX® ]

• 04260102133617: PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAM
• 04260102133587: PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAM
• 04260102132375: PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-
• 04260102131309: PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-
• 04260102131170: The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuu