BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    b-ONE™ 12/14 Taper Femoral Head

    DI: 00843575100009 · Model: 397175445 · B-ONE ORTHO, CORP.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    b-ONE™ 12/14 Taper Femoral Head
    Primary DI
    00843575100009
    Version / Model
    397175445
    Catalog Number
    397175445
    Company Name
    B-ONE ORTHO, CORP.
    Labeler DUNS
    081315444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-08
    Public Version
    2
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    39b42827-2df5-4530-b9c0-5f3e306b44ee

    Device Description

    Femoral Head, BIOLOX® delta ceramic; 28mm Diameter, -3.5mm Neck Length

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
    HWC Screw, Fixation, Bone
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    GMDN Terms

    Code Name
    38156 Ceramic femoral head prosthesis

    Identifiers

    Type ID
    Primary 00843575100009