BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InFill V2 Lateral PE

    DI: 00814729021723 · Model: V2-10-244010-PE · PINNACLE SPINE GROUP, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    InFill V2 Lateral PE
    Primary DI
    00814729021723
    Version / Model
    V2-10-244010-PE
    Company Name
    PINNACLE SPINE GROUP, LLC
    Labeler DUNS
    962347980
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-26
    Public Version
    4
    Public Version Date
    2019-04-23
    Public Version Status
    Update
    Public Device Record Key
    2cb71a11-fd31-4882-b3ed-ea362f3b853f

    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
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Radiation Sterilization", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    61533 Interspinous spinal fixation implant

    Identifiers

    Type ID
    Primary 00814729021723

    Premarket Submissions

    Submission Number Supplement Number
    K152259 000