BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Malleolar Procedure Kit

    DI: B562MPKCSST4050TUS0 · Model: MPK-CSST4050T-US · Wishbone Medical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Malleolar Procedure Kit
    Primary DI
    B562MPKCSST4050TUS0
    Version / Model
    MPK-CSST4050T-US
    Catalog Number
    MPK-CSST4050T
    Company Name
    Wishbone Medical, Inc.
    Labeler DUNS
    062355158
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-02-17
    Public Version
    4
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    067a4b90-5f83-40ff-9ab2-2614b7a5b211

    Device Description

    4.0mm x 50mm Cannulated Screw, Short Thread with Instruments, Ti

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HWC Screw, Fixation, Bone

    GMDN Terms

    Code Name
    46649 Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

    Identifiers

    Type ID
    Primary B562MPKCSST4050TUS0