BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ManaMed

    DI: 00810113681597 · Model: Mini 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
    00810113681597
    Version / Model
    Mini Kahuna Brace
    Catalog Number
    MKB001
    Company Name
    MANAMED INC
    Labeler DUNS
    084042331
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-10
    Public Version
    1
    Public Version Date
    2022-06-21
    Public Version Status
    New
    Public Device Record Key
    95b09a38-7ed7-486a-9264-d287ff7cd912

    Device Description

    The Mini Kahuna Brace is universal and can be applied to right or left side. The breathable material allows for comfort and optimal patient experience. The Mini Kahuna brace fits the description of the L3670 HCPC. Mini Kahuna comes with abduction pillow and ball. Universal Used for arthroscopic, anterior, or rotator cuff repairs

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    44878 Shoulder immobilizer/orthosis, single-use

    Identifiers

    Type ID
    Primary 00810113681597