BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ManaMed

    DI: 00810113680859 · Model: Kahuna Brace · MANAMED INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ManaMed
    Primary DI
    00810113680859
    Version / Model
    Kahuna Brace
    Catalog Number
    KB001
    Company Name
    MANAMED INC
    Labeler DUNS
    084042331
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-20
    Public Version
    1
    Public Version Date
    2022-06-28
    Public Version Status
    New
    Public Device Record Key
    0f38fa26-7f99-4f27-995c-edc39338c65d

    Device Description

    The Kahuna Brace provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Kahuna Brace is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation

    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
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IQQ Joint, Shoulder, External Limb Component

    GMDN Terms

    Code Name
    12101 Shoulder immobilizer/orthosis, reusable

    Identifiers

    Type ID
    Primary 00810113680859