BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ROMEO® 2

    DI: 07640151088323 · Model: ELL-IN 00 42-S · SpineArt SA
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ROMEO® 2
    Primary DI
    07640151088323
    Version / Model
    ELL-IN 00 42-S
    Catalog Number
    ELL-IN 00 42-S
    Company Name
    SpineArt SA
    Labeler DUNS
    483016148
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-27
    Public Version
    1
    Public Version Date
    2023-07-05
    Public Version Status
    New
    Public Device Record Key
    59aade53-32c9-40dd-9947-3392a3128330

    Device Description

    CEMENT FILLER PP

    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PML Bone Cement, Posterior Screw Augmentation
    NKB Thoracolumbosacral Pedicle Screw System
    KWP Appliance, Fixation, Spinal Interlaminal

    GMDN Terms

    Code Name
    47737 Orthopaedic cement injection cannula

    Identifiers

    Type ID
    Primary 07640151088323