BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BRACE BACK

    DI: 00840216105270 · Model: SWT210 · Asp Global, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BRACE BACK
    Primary DI
    00840216105270
    Version / Model
    SWT210
    Company Name
    Asp Global, LLC
    Labeler DUNS
    080361159
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-11
    Public Version
    2
    Public Version Date
    2023-04-24
    Public Version Status
    Update
    Public Device Record Key
    7d69029c-7644-4fd0-82cf-77c2032dab85
    Distribution End Date
    2023-04-21

    Device Description

    BRACE BACK, 1/EA

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MRI Orthosis, Truncal/Orthosis, Limb

    GMDN Terms

    Code Name
    33031 Lumbar spine orthosis

    Identifiers

    Type ID
    Primary 00840216105270