BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Equinoxe

    DI: 10885862558091 · Model: 311-09-01 · Exactech, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Equinoxe
    Primary DI
    10885862558091
    Version / Model
    311-09-01
    Catalog Number
    311-09-01
    Company Name
    Exactech, Inc.
    Labeler DUNS
    157565946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-28
    Public Version
    1
    Public Version Date
    2022-08-05
    Public Version Status
    New
    Public Device Record Key
    49f694c8-c3de-476e-9d2e-959ec00effa9

    Device Description

    HUM HEAD REMOVAL TOOL

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
    HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

    GMDN Terms

    Code Name
    63105 Orthopaedic instrument extractor

    Identifiers

    Type ID
    Primary 10885862558091

    Premarket Submissions

    Submission Number Supplement Number
    K042021 000
    K140063 000