BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-Fit Back Brace

    DI: 00859718007265 · Model: FLEBB0003 - Back · Emsi
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pro-Fit Back Brace
    Primary DI
    00859718007265
    Version / Model
    FLEBB0003 - Back
    Company Name
    Emsi
    Labeler DUNS
    932471881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-21
    Public Version
    1
    Public Version Date
    2023-03-29
    Public Version Status
    New
    Public Device Record Key
    5bdbf693-36b7-4d88-9cd0-4dfe7f06500c

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    No

    Product Codes

    Code Name
    IPY Orthosis, Lumbo-Sacral

    GMDN Terms

    Code Name
    33031 Lumbar spine orthosis

    Identifiers

    Type ID
    Primary 00859718007265