BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-PAC

    DI: 00850001720939 · Model: EI224508 · EXPANDING INNOVATIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-PAC
    Primary DI
    00850001720939
    Version / Model
    EI224508
    Company Name
    EXPANDING INNOVATIONS, INC.
    Labeler DUNS
    081309444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-30
    Public Version
    1
    Public Version Date
    2023-06-07
    Public Version Status
    New
    Public Device Record Key
    6070e561-3b81-4c69-9b50-bfc247ce7535

    Device Description

    X-PAC Lateral Cage 22mm x 45mm x 4 - 8 degrees

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    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
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00850001720939

    Customer Contacts

    Phone
    650 861 3129
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K223174 000