PALAMIX® 66057893

GUDID 04260102133587

PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.

Heraeus Medical GmbH

Manual orthopaedic cement mixer, single-use

• Primary Device ID: 04260102133587
• NIH Device Record Key: a15a0f9a-543c-4e41-935b-b75fd98b5517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALAMIX®
• Version Model Number: UNO
• Catalog Number: 66057893
• 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: 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260102133587 [Primary]
GS1	04260102133594 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	04260102133600 [Package]; Package: [160 Units]; In Commercial Distribution

FDA Product Code

• JDZ: Mixer, Cement, For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-13
• Device Publish Date: 2018-03-16

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