BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 1526711 · FEI: 1526711 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC
    Registration Number
    1526711
    FEI Number
    1526711
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4405 MARKETING PLACE
    City
    GROVEPORT
    State
    OH
    ZIP
    43125
    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)