BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dymaxeon

    DI: 00815500025343 · Model: 06.0 · BACK 2 BASIC DIRECT, LLC
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dymaxeon
    Primary DI
    00815500025343
    Version / Model
    06.0
    Catalog Number
    77.2046
    Company Name
    BACK 2 BASIC DIRECT, LLC
    Labeler DUNS
    043841348
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-12
    Public Version
    1
    Public Version Date
    2019-03-20
    Public Version Status
    New
    Public Device Record Key
    d806889b-8d40-4043-9267-04640ce11f43

    Device Description

    Probe - Lenke - Curved - Palm Handle

    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
    MR Conditional
    Direct Marking Exempt
    Yes
    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
    NKB Thoracolumbosacral Pedicle Screw System
    MNI Orthosis, Spinal Pedicle Fixation
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    GMDN Terms

    Code Name
    44795 Manual orthopaedic bender, reusable

    Identifiers

    Type ID
    Primary 00815500025343

    Customer Contacts

    Phone
    216-447-5025
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K121786 000