BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OpenLoc-L Spinal Fixation System

    DI: 08806344360426 · Model: 1354-6020 · L&K BIOMED CO. ,LTD.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OpenLoc-L Spinal Fixation System
    Primary DI
    08806344360426
    Version / Model
    1354-6020
    Catalog Number
    1354-6020
    Company Name
    L&K BIOMED CO. ,LTD.
    Labeler DUNS
    631159324
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-15
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    d83a98a7-f988-4e81-ba15-91c028156e89

    Device Description

    Reduction Poly Axial Screw Ø6.0, 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
    NKB Thoracolumbosacral Pedicle Screw System
    KWQ Appliance, Fixation, Spinal Intervertebral Body

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 08806344360426