BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Novation Element

    DI: 10885862035530 · Model: 165-00-08 · Exactech, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Novation Element
    Primary DI
    10885862035530
    Version / Model
    165-00-08
    Catalog Number
    165-00-08
    Company Name
    Exactech, Inc.
    Labeler DUNS
    157565946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-25
    Public Version
    1
    Public Version Date
    2022-09-02
    Public Version Status
    New
    Public Device Record Key
    d009eba5-da85-41e6-a1e6-c37934a40034

    Device Description

    BROACH, SIZE 8

    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
    MEH Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate

    GMDN Terms

    Code Name
    36167 Orthopaedic broach

    Identifiers

    Type ID
    Primary 10885862035530

    Premarket Submissions

    Submission Number Supplement Number
    K080980 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify SIZE 8