BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ManuMix

    DI: 04260056881565 · Model: 02-0601 · OSARTIS GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ManuMix
    Primary DI
    04260056881565
    Version / Model
    02-0601
    Catalog Number
    02-0602
    Company Name
    OSARTIS GmbH
    Labeler DUNS
    344261631
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-12
    Public Version
    1
    Public Version Date
    2021-10-20
    Public Version Status
    New
    Public Device Record Key
    dfad0214-b60b-48f6-b9d4-481fda4602bf

    Device Description

    ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JDZ Mixer, Cement, For Clinical Use

    GMDN Terms

    Code Name
    61468 Manual orthopaedic cement mixer, single-use

    Identifiers

    Type ID
    Package 04260056881572
    Primary 04260056881565