BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Hyperice / NormaTec

    DI: 00810050288026 · Model: HX20001 · NORMATEC INDUSTRIES LP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Hyperice / NormaTec
    Primary DI
    00810050288026
    Version / Model
    HX20001
    Company Name
    NORMATEC INDUSTRIES LP
    Labeler DUNS
    111448069
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-25
    Public Version
    1
    Public Version Date
    2025-08-04
    Public Version Status
    New
    Public Device Record Key
    064ce28d-a431-4860-b6c5-d35ab2a8dd25

    Device Description

    HYPERICE X2 KNEE

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    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
    ILO Pack, Hot Or Cold, Water Circulating

    GMDN Terms

    Code Name
    64765 Hot/cold therapy system

    Identifiers

    Type ID
    Primary 00810050288026