BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MOBIO™ Total Knee System

    DI: 00843575109705 · Model: 8821313316 · B-ONE ORTHO, CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MOBIO™ Total Knee System
    Primary DI
    00843575109705
    Version / Model
    8821313316
    Catalog Number
    8821313316
    Company Name
    B-ONE ORTHO, CORP.
    Labeler DUNS
    081315444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-17
    Public Version
    1
    Public Version Date
    2023-05-25
    Public Version Status
    New
    Public Device Record Key
    9e9eb374-9cf7-4985-890d-794175dcc890

    Device Description

    CR PLUS Tibial Insert, Vitamin E UHMWPE, Size DE/4-6+, 16 mm

    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
    OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

    GMDN Terms

    Code Name
    46585 Tibial insert

    Identifiers

    Type ID
    Primary 00843575109705