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    Mini and Micro Fragments Reconstruction System - GMReis

    DI: 07899258624525 · Model: Cortical Screw · GM DOS REIS INDUSTRIA E COMERCIO LTDA
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mini and Micro Fragments Reconstruction System - GMReis
    Primary DI
    07899258624525
    Version / Model
    Cortical Screw
    Catalog Number
    223-24-50-CPB
    Company Name
    GM DOS REIS INDUSTRIA E COMERCIO LTDA
    Labeler DUNS
    900865213
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-01-24
    Public Version
    1
    Public Version Date
    2024-02-01
    Public Version Status
    New
    Public Device Record Key
    2daf2e2b-c23a-4b1b-bf80-ca94b78ec1c2

    Device Description

    CORTICAL SCREW TORXDRIVE Ti T7 Ø2,4x50mm LOW PROFILE

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HRS Plate, Fixation, Bone
    HWC Screw, Fixation, Bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 07899258624525

    Premarket Submissions

    Submission Number Supplement Number
    K182718 000