BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Volition™ Plating System

    DI: 05055662962949 · Model: OS721004-NS · ORTHO SOLUTIONS HOLDINGS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Volition™ Plating System
    Primary DI
    05055662962949
    Version / Model
    OS721004-NS
    Catalog Number
    OS721004-NS
    Company Name
    ORTHO SOLUTIONS HOLDINGS LIMITED
    Labeler DUNS
    218648211
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-25
    Public Version
    1
    Public Version Date
    2021-07-05
    Public Version Status
    New
    Public Device Record Key
    d36de2a5-8e33-4a21-81f3-934437934bf1

    Device Description

    PLATE BENDING IRON

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    HXP Instrument, Bending Or Contouring

    GMDN Terms

    Code Name
    47637 Bone fixation plate pliers

    Identifiers

    Type ID
    Primary 05055662962949

    Customer Contacts

    Phone
    +441621843599
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K202764 000