BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Opal Cool Wrap with SkinSafe58

    Reg #: 3016555200 · FEI: 3016555200 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    XENA COOL LLC
    Registration Number
    3016555200
    FEI Number
    3016555200
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    957 Tile Drive
    City
    Red Wing
    State
    MN
    ZIP
    55066
    Country
    US

    Owner / Operator

    Firm Name
    XENA VENTURES LLC
    Operator Number
    10062560
    Address
    145 Maple Hill Rd
    City
    Hopkins
    State
    MN
    Postal Code
    55343
    Country
    US
    Correspondent
    Tammy Lee

    Products

    Device Name Product Code
    Pack, Hot Or Cold, Reusable IME

    Proprietary Names

    Opal Cool Wrap with SkinSafe58 ONYX COOL NOW VEST (80) Opal Cool Gal Pals with SkinSafe 58 Opal Cool Now Pad (80) ONYX COOL NOW BACK/HIP/ARM WRAP (80) ONYX COOL VEST with SkinSafe 58 ONYX COOL NOW CAP (80) ONYX COOL BACK/HIP/ARM WRAP with SkinSafe 58 Opal Cool Cap with SkinSafe58 Opal Cool Now Gal Pals (80) Opal Cool One with SkinSafe58 ONYX COOL CAP with SkinSafe58 ONYX COOL KNEE WRAP with SkinSafe 58 ONYX COOL SHOULDER/FOOT WRAP with SkinSafe 58 ONYX COOL NOW PAD (80) Opal Cool Eye Mask with SkinSafe58

    Establishment Types

    Manufacture Medical Device