BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PERFORMANCE HEALTH

    DI: 00840216112407 · Model: 798507 · Asp Global, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PERFORMANCE HEALTH
    Primary DI
    00840216112407
    Version / Model
    798507
    Company Name
    Asp Global, LLC
    Labeler DUNS
    080361159
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-03
    Public Version
    1
    Public Version Date
    2022-08-11
    Public Version Status
    New
    Public Device Record Key
    440b4c07-3b1b-4a4e-b52d-41e052494ec1

    Device Description

    Rolyan Post-op Shoe, XL, Men

    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
    KNP Orthosis, Corrective Shoe

    GMDN Terms

    Code Name
    31041 Orthotic shoe, non-customized

    Identifiers

    Type ID
    Primary 00840216112407