BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    EasyDrill Cranial Perforator 14 x 11 x 1,5mm (DM0210FAA)

    Reg #: 3010370650 · FEI: 3010165944 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COMPANHIA BRASILEIRA DE ESTERILIZACAO
    Registration Number
    3010370650
    FEI Number
    3010165944
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida do Progresso, 900 Ponte Alta
    City
    Jarinu Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K141455

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Drills, Burrs, Trephines & Accessories (Compound, Powered) HBF

    Proprietary Names

    EasyDrill Cranial Perforator 14 x 11 x 1,5mm (DM0210FAA) EasyDrill Cranial Perforator 14 x 11 x 3mm (DM0010FAA) EasyDrill Cranial Perforator 11 x 7 x 3mm (DM0011FAA) EasyDrill Cranial Perforator 9 x 6 x 3mm (DM0008FAA)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)