BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Boston Body Jacket, Bivalve Opening

    DI: 00860014460814 · Model: Boston Body Jacket, Bivalve Opening · Boston Brace International, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Boston Body Jacket, Bivalve Opening
    Primary DI
    00860014460814
    Version / Model
    Boston Body Jacket, Bivalve Opening
    Catalog Number
    Boston Body Jacket, Bivalve Opening
    Company Name
    Boston Brace International, Inc.
    Labeler DUNS
    801816158
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-05
    Public Version
    1
    Public Version Date
    2025-08-13
    Public Version Status
    New
    Public Device Record Key
    0903eeb6-170f-4ee5-a9c1-4b4b8770663c

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IQE Orthosis, Lumbar
    IPT Orthosis, Thoracic

    GMDN Terms

    Code Name
    66086 Multiple spinal region orthosis

    Identifiers

    Type ID
    Primary 00860014460814