BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Orpyx Sensory Insoles

    DI: 10185571000400 · Model: ORPYXSIV1 · Orpyx
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Orpyx Sensory Insoles
    Primary DI
    10185571000400
    Version / Model
    ORPYXSIV1
    Catalog Number
    10185571000400
    Company Name
    Orpyx
    Labeler DUNS
    250917031
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-07
    Public Version
    1
    Public Version Date
    2025-02-17
    Public Version Status
    New
    Public Device Record Key
    b41faa9c-0ae5-4580-9dcc-272317d6cdd3

    Device Description

    Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: pre-fabricated sensory insoles - instructions for use manual

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    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
    IRN Device, Warning, Overload, External Limb, Powered
    OIZ Foot Examination Tool For Inflammatory Changes

    GMDN Terms

    Code Name
    61782 Pressure monitoring insole

    Identifiers

    Type ID
    Primary 10185571000400