BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    1.5mm H&F H-Plate, 6x2 Holes, 1.5mm/2.0mm/2.4mm

    DI: 00840118102483 · Model: FHF 465 · FLOWER ORTHOPEDICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    1.5mm H&F H-Plate, 6x2 Holes, 1.5mm/2.0mm/2.4mm
    Primary DI
    00840118102483
    Version / Model
    FHF 465
    Company Name
    FLOWER ORTHOPEDICS CORPORATION
    Labeler DUNS
    078790947
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-06-04
    Public Version
    3
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    bd7ba05e-93b3-4607-a3ce-5502a72c85e4

    Device Description

    implants for orthopedic bone fixation

    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
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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 00840118102483

    Customer Contacts

    Phone
    8777788587
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K123562 000

    Device Sizes

    Type Value Unit Text
    Height 1.5 Millimeter