BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SOLE MEDIAL COLUMN FUSION PLATE

    DI: 18053340346641 · Model: 1 · ORTHOFIX SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SOLE MEDIAL COLUMN FUSION PLATE
    Primary DI
    18053340346641
    Version / Model
    1
    Catalog Number
    99-84010R
    Company Name
    ORTHOFIX SRL
    Labeler DUNS
    438793622
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-06-03
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    fa899399-6b99-44f8-8dd5-412428727d83

    Device Description

    SOLE MCF SS PLATE STANDARD LARGE RIGHT STERILE

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HRS Plate, Fixation, Bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 18053340346641

    Customer Contacts

    Phone
    +0390456719000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K210157 000

    Device Sizes

    Type Value Unit Text
    Height 2 Millimeter