BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StrykerPR3324 (GR, VG) - 4MM 60 DEG. AGG SERR BLADE

    Reg #: 2648623 · FEI: 2648623 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    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
    K073633

    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
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    StrykerPR3324 (GR, VG) - 4MM 60 DEG. AGG SERR BLADE Stryker Puerto Rico - 4MM 40 DEG. AGG SERR BLADE Stryker3324 (GR) - 4mm Jaguar Blade StrykerPR3324 (GR, VG) - 4mm JAGUAR BLADE StrykerPR3324 (GR, VG) - 3.5mm JAGUAR BLADE StrykerPR3324 (GR, VG) - 3.5mm 60 Degree Angled Aggressive Serrated Blade StrykerPR3324 (GR, VG) - 2.5mm AGGRESSIVE BLADE 11cm Stryker Puerto Rico - 2mm ROUND BUR StrykerPR3324 (GR, VG) - 3mm ROUND BUR StrykerPR3324 (GR, VG) - 4mm ANGLED AGGRESSIVE 40 DEG StrykerPR3324 (GR, VG) - 4mm Aggressive Blade 11CM StrykerPR3324 (GR, VG) - 3.5mm Aggressive Blade StrykerPR3324 (GR, VG) - 2.5mm Aggressive Blade StrykerPR3324 (GR, VG) - 4mm Aggressive Blade StrykerPR3324 (GR, VG) - 4mm ANGLED AGGRESSIVE 60 DEG Stryker Puerto Rico - 4mm AGGRESSIVE BLADE StrykerPR324 (GR, VG) - 3.5mm 40 Deg. Agg. Serrated StrykerPR 3324 (GR, VG) - 4mm AGGRESSIVE SERRATE StrykerPR3324 (GR, VG) - 4mm Angle Aggressive Blade StrykerPR3324 (GR, VG) - 4mm SHARPEDGE BLADE StrykerPR3324 (GR) - 4MM 60 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 4mm Sharpedge Stryker3324 (GR) - 3.5mm 60 Degree Angle Aggressive Serrated Blade StrykerPR3324 (GR, LS) - 4mm Agle Aggressive Blade StrykerPR3324 (GR, VG) - 3.5mm Aggressive Serrated StrykerPR3324 (GR, VG) - 3.5mm Jaguar Blade Stryker3324 (GR) - 3mm Round Bur StrykerPR3324 (GR, VG) - 4MM 40 DEG. AGG SERR BLADE StrykerPR3324 (GR, VG) - 4mm 60 Degree Angle Aggressive Balde StrykerPR3324 (GR, VG - 3.5mm 40 Degree Angled Aggressive Serrated Blade StrykerPR3324 (GR, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)