PALAMIX®

Basic Information

• Brand Name: PALAMIX®
• Primary DI: 04260102131231
• Version / Model: Vacuum Pump
• Catalog Number: 66036748
• Company Name: Heraeus Medical GmbH
• Labeler DUNS: 333623937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-15
• Public Version: 1
• Public Version Date: 2019-05-23
• Public Version Status: New
• Public Device Record Key: 63cf5226-050e-49ec-97ba-d740b189d2ac

Device Description

Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDY	Evacuator, Vapor, Cement Monomer	Orthopedic	888.4220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60520	Orthopaedic material preparation vacuum pump	A pneumatically-powered device intended to create negative pressure (vacuum) during orthopaedic cement/filler mixing to help improve the quality of the resulting cement/filler (e.g., reduced porosity and fatigue). It is typically a portable unit containing a pump with a pressure dial/display and control(s), and is usually used in conjunction with an orthopaedic cement-mixing container and fume evacuation/filtering devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260102131231	GS1