BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3.5mm x 44mm Cortex Screw

    DI: 00814289021348 · Model: SC3544 · CONVENTUS ORTHOPAEDICS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3.5mm x 44mm Cortex Screw
    Primary DI
    00814289021348
    Version / Model
    SC3544
    Company Name
    CONVENTUS ORTHOPAEDICS, INC.
    Labeler DUNS
    021231299
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-22
    Public Version
    3
    Public Version Date
    2024-02-19
    Public Version Status
    Update
    Public Device Record Key
    2dd7a9c1-0ae2-4ec1-9932-08cb4d724358

    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
    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
    JDS Nail, Fixation, Bone
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    61689 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

    Identifiers

    Type ID
    Primary 00814289021348