BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

    DI: 05055662917772 · Model: OS332150R · ORTHO SOLUTIONS HOLDINGS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
    Primary DI
    05055662917772
    Version / Model
    OS332150R
    Catalog Number
    OS332150R
    Company Name
    ORTHO SOLUTIONS HOLDINGS LIMITED
    Labeler DUNS
    218648211
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-20
    Public Version
    5
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    a7796a1e-9cbf-4790-8d8e-8ed3981d7be2

    Device Description

    OXFORD ANKLE FUSION NAIL 12MM X 150MM (Ti6Al4V)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    HSB Rod, Fixation, Intramedullary And Accessories

    GMDN Terms

    Code Name
    44854 Arthrodesis nail, fixed-length

    Identifiers

    Type ID
    Primary 05055662917772

    Customer Contacts

    Phone
    +441621843599
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K121575 000