BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit

    Reg #: 2648623 · FEI: 2648623 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STERIS ISOMEDIX PUERTO RICO, INC.
    Registration Number
    2648623
    FEI Number
    2648623
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KM 1 7, STATE Road, 690, BARRIO SABANA HOYOS
    City
    Alts De Cerro Gordo 3&4
    State
    PR
    ZIP
    00692
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032943

    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
    Instrument, Biopsy KNW

    Proprietary Names

    StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit StrykerPR3324 (GR,VG) - 10G Biopsy Kit StrykerPR3324 (GR, LS, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G StrykerPR3324 (GR) - 10 G Bone Biopsy kit StrykerPR3324 (GR,VG) - 13G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 8 Gauge Biopsy StrykerPR3324 (GR, LS, VG) - 11G Bone Biopsy Kit StrykerPR3324 (GR,VG) - 9" 10G Bone Biopsy Kit

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)