BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rampart O

    DI: M7402800003 · Model: 83-04-07-9 · SPINEOLOGY INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rampart O
    Primary DI
    M7402800003
    Version / Model
    83-04-07-9
    Catalog Number
    280-0003
    Company Name
    SPINEOLOGY INC.
    Labeler DUNS
    033014361
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-28
    Public Version
    1
    Public Version Date
    2018-09-28
    Public Version Status
    New
    Public Device Record Key
    535989ac-0dca-4797-9c47-f49f28567f31

    Device Description

    9x25mm Trial

    Device Characteristics

    Single Use
    No
    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    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
    61609 Vertebral body bone graft pouch

    Identifiers

    Type ID
    Primary M7402800003

    Customer Contacts

    Phone
    +1(651)256-8500 ext. 513
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K160906 000

    Device Sizes

    Type Value Unit Text
    Height 9 Millimeter
    Device Size Text, specify 9x25mm Trial