BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sleeve

    DI: 07613327016468 · Model: 17-0000E · Howmedica Osteonics Corp.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sleeve
    Primary DI
    07613327016468
    Version / Model
    17-0000E
    Catalog Number
    17-0000E
    Company Name
    Howmedica Osteonics Corp.
    Labeler DUNS
    058311945
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6e43daaa-4be4-464b-9584-142b5ec66fbc

    Device Description

    Use Only with V40 Taper Stems

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

    GMDN Terms

    Code Name
    59688 Femoral head/stem prosthesis adaptor

    Identifiers

    Type ID
    Primary 07613327016468

    Premarket Submissions

    Submission Number Supplement Number
    K003379 000
    K051737 000