BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avanos2508 (EP1,EP2) - Cytology Brush

    Reg #: 3009888344 · FEI: 3009888344 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations Inc
    Registration Number
    3009888344
    FEI Number
    3009888344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1441 Don Haskins Dr
    City
    El Paso
    State
    TX
    ZIP
    79936
    Country
    US

    Regulatory Submissions

    510(k) Number
    K941464

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Endoscopic Cytology Brush FDX
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ

    Proprietary Names

    Avanos2508 (EP1,EP2) - Cytology Brush Avanos2508 (EP1,EP2) - Endoscopic Accessories

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)