BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gebauer's Instant Ice

    Reg #: 1519179 · FEI: 1519179 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GEBAUER CO.
    Registration Number
    1519179
    FEI Number
    1519179
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4444 E. 153RD ST.
    City
    Cleveland
    State
    OH
    ZIP
    44128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021726

    Owner / Operator

    Firm Name
    GEBAUER CO.
    Operator Number
    9002736
    Address
    4444 E. 153RD ST., --
    City
    Garfield Hts
    State
    OH
    Postal Code
    44128
    Country
    US
    Correspondent
    AMY J PAUKOVITS

    Products

    Device Name Product Code
    Vapocoolant Device MLY

    Proprietary Names

    Gebauer's Instant Ice

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198