BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Tattoo Arm Sleeve Cover Barrier

    DI: 00616784213729 · Model: 2137 · DYNAREX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    100

    Basic Information

    Brand Name
    Disposable Tattoo Arm Sleeve Cover Barrier
    Primary DI
    00616784213729
    Version / Model
    2137
    Company Name
    DYNAREX CORPORATION
    Labeler DUNS
    008124539
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    100
    Record Status
    Published
    Publish Date
    2021-06-21
    Public Version
    2
    Public Version Date
    2021-11-23
    Public Version Status
    Update
    Public Device Record Key
    8e020a52-c256-4eb2-84f8-f8dab200de36

    Device Description

    Disposable Tattoo Arm Sleeve Cover Barrier, Poly, Blue, Universal

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    No
    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
    FXP Cover, Shoe, Operating-Room

    GMDN Terms

    Code Name
    43222 Limb-worn device hygienic cover

    Identifiers

    Type ID
    Package 00616784213736
    Primary 00616784213729
    Unit of Use 00616784213712