BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Equinoxe®

    DI: 10885862622464 · Model: 324-40-03 · Exactech, Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Equinoxe®
    Primary DI
    10885862622464
    Version / Model
    324-40-03
    Catalog Number
    324-40-03
    Company Name
    Exactech, Inc.
    Labeler DUNS
    157565946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-11-28
    Public Version
    1
    Public Version Date
    2023-12-06
    Public Version Status
    New
    Public Device Record Key
    9725593a-a822-4683-9cd9-2ed8884ef251

    Device Description

    Humeral Liner

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
    KWT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
    PHX shoulder prosthesis, reverse configuration

    GMDN Terms

    Code Name
    48092 Polyethylene reverse shoulder prosthesis cup

    Identifiers

    Type ID
    Primary 10885862622464

    Premarket Submissions

    Submission Number Supplement Number
    K223833 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify +2.5mm
    Angle 135 degree
    Device Size Text, specify 40mm