BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BiMobile

    DI: 04026575174546 · Model: 184-201/52 · WALDEMAR LINK GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BiMobile
    Primary DI
    04026575174546
    Version / Model
    184-201/52
    Catalog Number
    184-201/52
    Company Name
    WALDEMAR LINK GmbH & Co. KG
    Labeler DUNS
    315675488
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-24
    Public Version
    3
    Public Version Date
    2020-09-09
    Public Version Status
    Update
    Public Device Record Key
    9ea00ad0-e237-4746-a2dc-6c8da860d731

    Device Description

    BiMobile Cup - PlasmaLink

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

    GMDN Terms

    Code Name
    43167 Acetabular shell

    Identifiers

    Type ID
    Primary 04026575174546

    Premarket Submissions

    Submission Number Supplement Number
    K171273 000