BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Game Ready C-T Spine Wrap - Large - Rental

    DI: 00812120003881 · Model: 590502-03-RN · Avanos Medical, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Game Ready C-T Spine Wrap - Large - Rental
    Primary DI
    00812120003881
    Version / Model
    590502-03-RN
    Catalog Number
    590502-03-RN
    Company Name
    Avanos Medical, Inc.
    Labeler DUNS
    079375431
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-05
    Public Version
    2
    Public Version Date
    2023-12-18
    Public Version Status
    Update
    Public Device Record Key
    2750388d-6c5c-4725-b898-1819ab3cf64a

    Device Description

    590502-03-RN ATX WRAP CT SPINE LG RNTL,1

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    IRP Massager, powered inflatable tube

    GMDN Terms

    Code Name
    60708 Circulating-fluid localized thermal/compression therapy system wrap

    Identifiers

    Type ID
    Primary 00812120003881

    Customer Contacts

    Phone
    +1(844)428-2667
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K192114 000