BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INSTRUMENT

    DI: 07613327220308 · Model: 6278-3-150 · Howmedica Osteonics Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INSTRUMENT
    Primary DI
    07613327220308
    Version / Model
    6278-3-150
    Catalog Number
    6278-3-150
    Company Name
    Howmedica Osteonics Corp.
    Labeler DUNS
    058311945
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    15780f43-98ef-4119-b514-7226d6055533

    Device Description

    RESTORATION MODULAR INST SYS BROACH TIP

    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
    Yes
    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
    LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    GMDN Terms

    Code Name
    36167 Orthopaedic broach

    Identifiers

    Type ID
    Primary 07613327220308

    Device Sizes

    Type Value Unit Text
    Length 127.0 Millimeter
    Device Size Text, specify Diameter: 15.0 Millimeter