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    FDA UDI In Commercial Distribution 🇺🇸 United States

    EASYMIX® vacuum pump II

    DI: 04260056881930 · Model: 02-0201 · OSARTIS GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EASYMIX® vacuum pump II
    Primary DI
    04260056881930
    Version / Model
    02-0201
    Catalog Number
    02-0201
    Company Name
    OSARTIS GmbH
    Labeler DUNS
    344261631
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-01
    Public Version
    1
    Public Version Date
    2022-12-09
    Public Version Status
    New
    Public Device Record Key
    ab0826bf-7ba5-4b46-9abe-0a42bf158a90

    Device Description

    The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room. The EASYMIX® II vacuum pump is equipped with an indicator for functionality.

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JDY Evacuator, Vapor, Cement Monomer

    GMDN Terms

    Code Name
    60520 Orthopaedic material preparation vacuum pump

    Identifiers

    Type ID
    Primary 04260056881930