BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Distal Tibial A-Plate

    DI: 00840118109079 · Model: DAT 005 · FLOWER ORTHOPEDICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Distal Tibial A-Plate
    Primary DI
    00840118109079
    Version / Model
    DAT 005
    Company Name
    FLOWER ORTHOPEDICS CORPORATION
    Labeler DUNS
    078790947
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-09-15
    Public Version
    4
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    4fc11141-6df4-430d-963e-e2f75ac6cd06

    Device Description

    Implants for orthopedic bone fixation, compatible with 2.7mm/3.5/4.0mm screws

    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 00840118109079

    Customer Contacts

    Phone
    8777788587
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K133102 000