BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trial Neck Reacher 37.5-50

    DI: 09348215055530 · Model: 111-242-153 · SIGNATURE ORTHOPAEDICS PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trial Neck Reacher 37.5-50
    Primary DI
    09348215055530
    Version / Model
    111-242-153
    Company Name
    SIGNATURE ORTHOPAEDICS PTY LTD
    Labeler DUNS
    751993028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-10-30
    Public Version
    1
    Public Version Date
    2019-11-07
    Public Version Status
    New
    Public Device Record Key
    1f4c8040-fec5-4447-889f-ace638fb5a61

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    LXH Orthopedic Manual Surgical Instrument

    GMDN Terms

    Code Name
    46479 Surgical implant template, reusable

    Identifiers

    Type ID
    Primary 09348215055530

    Premarket Submissions

    Submission Number Supplement Number
    K133370 000