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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Juliet® OL Lumbar Interbody Device

    DI: 07640139345264 · Model: JUL-OL 28 14-N · SpineArt SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Juliet® OL Lumbar Interbody Device
    Primary DI
    07640139345264
    Version / Model
    JUL-OL 28 14-N
    Catalog Number
    JUL-OL 28 14-N
    Company Name
    SpineArt SA
    Labeler DUNS
    483016148
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-27
    Public Version
    2
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    35b1905c-0314-422a-b597-b98148c9d2c7

    Device Description

    Straight Transforaminal Lumbar Cage

    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 07640139345264

    Device Sizes

    Type Value Unit Text
    Length 28 Millimeter
    Height 14 Millimeter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius