BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RONDO-PAK

    Reg #: 3013770781 · FEI: 3013770781 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    RONDO-PAK
    Registration Number
    3013770781
    FEI Number
    3013770781
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1200 Ferry Ave
    City
    Camden
    State
    NJ
    ZIP
    08104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K000408

    Owner / Operator

    Firm Name
    Rondo-Pak
    Operator Number
    10087400
    Address
    1200 Ferry Ave
    City
    Camden
    State
    NJ
    Postal Code
    08104
    Country
    US

    Products

    Device Name Product Code
    Condom HIS
    Condom, Synthetic MOL
    Lubricant, Personal NUC
    Condom With Nonoxynol-9 LTZ

    Proprietary Names

    LifeStyles (Flavors & Colors) Lifestyles Closer Connection SKYN Excitation SKYN Selection (Excitation) SKYN All Night Long LifeStyles Non-Lubricated SKYN Naturally Endless SKYN Elite SKYN Selection (SKYN Elite) SKYN KING LARGE SKYN Cocktail Club SKYN KING SKYN Original SKYN Elite Large SKYN KING ELITE LARGE SKYN KING ELITE LARGE EXTRA GLIDE SKYN Large SKYN Selection (SKYN Original) SKYN Snug Fit SKYN Selection (SKYN Elite Extra Lube) SKYN Supreme Feel Non-Latex Condom Lifestyles Snugger Fit Lifestyles Ultra Sensitive LifeStyles Large

    Establishment Types

    Repack or Relabel Medical Device