BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    StabiliT MX Fracture Kit

    DI: 00850696006479 · Model: MX-1100L · Dfine, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    StabiliT MX Fracture Kit
    Primary DI
    00850696006479
    Version / Model
    MX-1100L
    Catalog Number
    MX-1100L
    Company Name
    Dfine, Inc.
    Labeler DUNS
    169957607
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-11-02
    Public Version
    5
    Public Version Date
    2020-06-19
    Public Version Status
    Update
    Public Device Record Key
    5646fe01-4a88-4803-92d7-b184b0d8a788
    Distribution End Date
    2020-04-10

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NDN Cement, Bone, Vertebroplasty

    GMDN Terms

    Code Name
    35217 Orthopaedic cement, non-antimicrobial

    Identifiers

    Type ID
    Primary 00850696006479