BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ODI Talon™ Intramedullary Hip Nail

    DI: B058THN0011 · Model: THN001 · Orthopedic Designs North America, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ODI Talon™ Intramedullary Hip Nail
    Primary DI
    B058THN0011
    Version / Model
    THN001
    Company Name
    Orthopedic Designs North America, Inc.
    Labeler DUNS
    945518848
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-22
    Public Version
    4
    Public Version Date
    2023-05-03
    Public Version Status
    Update
    Public Device Record Key
    7108d18e-0db9-42ae-b28d-82f0ba79da3c

    Device Description

    Lag Sleeve

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    JDS Nail, Fixation, Bone

    GMDN Terms

    Code Name
    56640 Orthopaedic implant-instrument extension adaptor, single-use

    Identifiers

    Type ID
    Primary B058THN0011

    Customer Contacts

    Phone
    888-635-8535
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K014189 000