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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medyssey Spinal System - Deformity

    DI: 08806364642397 · Model: IMCL5555 · Medyssey Co., Ltd.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medyssey Spinal System - Deformity
    Primary DI
    08806364642397
    Version / Model
    IMCL5555
    Company Name
    Medyssey Co., Ltd.
    Labeler DUNS
    688211503
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-18
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    071f7f17-e281-4882-93b4-64e983290804

    Device Description

    Open Monoaxial Transverse Connector, for Ø5.5mm Rod, With Ø5.5mm Shaft, Length 20mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    KWP Appliance, Fixation, Spinal Interlaminal
    MNH Orthosis, Spondylolisthesis Spinal Fixation
    MNI Orthosis, Spinal Pedicle Fixation

    GMDN Terms

    Code Name
    61325 Bone-screw internal spinal fixation system, non-sterile

    Identifiers

    Type ID
    Primary 08806364642397