BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PKG., BARREL BUR, 8 FLUTE F-SERIES - 5.5MM

    Reg #: 2648045 · FEI: 2648045 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    84
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EDWARDS LIFESCIENCES TECHNOLOGY SARL
    Registration Number
    2648045
    FEI Number
    2648045
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    STATE ROAD 402, KM 1.4, Industrial Park
    City
    ANASCO
    State
    PR
    ZIP
    00610
    Country
    US

    Owner / Operator

    Firm Name
    Edwards Lifesciences LLC
    Operator Number
    9040666
    Address
    One Edwards Way
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Denny Kouri

    Products

    Device Name Product Code
    Bur, Surgical, General & Plastic Surgery GFF

    Proprietary Names

    PKG., BARREL BUR, 8 FLUTE F-SERIES - 5.5MM PKG., UNHOODED BARREL BUR, 6 FLUTE F- SERIES - 5.5MM PKG., ROUND BUR LONG HIP, F-SERIES, 8 FLUTE - 5.5MM PKG., RESECTOR SHAVER BLADE, F - SERIES - 4MM PKG., HOODED ABRASION BUR, SMALL JOINT F - SERIES - 3MM PKG., ANGLED RESECTOR SHAVER BLADE F-SERIES - 4.5MM PKG., TOMCAT SHAVER BLADE, F - SERIES - 5.5MM PKG., XL ANGLED AGG. PLUS LONG HIP BLADE F-SERIESSSS - 4MM PKG., SCALLOPED SHAVER BLADE, F - SERIES - 5.5MM PKG., FULL RADIUS SHAVER BLADE, SMALL JOINT, F - SERIES - 2.5MM PKG., WHISKER SHAVER BLADE, F - SERIES - 4MM PKG., BARREL BUR, 6 FLUTE F - SERIES - 4MM PKG., UNHOODED ROUND BUR, 6 FLUTE F - SERIES - 5.5MM PKG., PARALLELPORTAL CUTTER, DOUBLE BEND AGG. PLUS 3.5MM, BOX OF 5 PKG., ANGLED DBL. BITE SHAVER BLADE F - SERIES - 4.5MM PKG., SLOTTED WHISKER SHAVER BLADE, F - SERIES - 5MM PKG., AGG. PLUS SHAVER BLADE, SMALL JOINT, F - SERIES - 3.5MM PKG., SCALLOPED SHAVER BLADE, F - SERIES - 4MM PKG., PARALLELPORTAL CUTTER, SINGLE BEND RESECTOR 4MM, BOX OF 5 PKG., BARREL BUR, 6 FLUTE F - SERIES - 5.5MM PKG., ROUND BUR, 12 FLUTE F - SERIES - 5.5MM PKG., RESECTOR SHAVER BLADE, F - SERIES - 5MM PKG., AGG. PLUS SHAVER BLADE, F - SERIES - 5MM PKG., SUBCHONDRAL DRILL F-SERIES - 4MM PKG., PARALLELPORTAL CUTTER, DOUBLE BEND TOMCAT 4MM, BOX OF 5 PKG., END CUTTER SHAVER BLADE, F - SERIES - 3.5MM PKG., COUGAR SHAVER BLADE, F - SERIES - 5MM PKG., ROUND BUR, 6 FLUTE, F-SERIES - 3.5MM PKG., PARALLELPORTAL CUTTER, SINGLE BEND AGG. PLUS 4MM, BOX OF 5 PKG., END CUTTER SHAVER BLADE, F - SERIES - 4MM PKG., AGG. PLUS SHAVER BLADE, F - SEREIES - 5.5MM PKG., PARALLELPORTAL CUTTER, DOUBLE BEND TOMCAT 3.5MM, BOX OF 5 PKG., LONG HIP PEAR BUR, 8 FLUTE F-SERIES - 4MM PKG., BARREL BUR, 6 FLUTE F-SERIES - 5MM PKG., AGG. PLUS LONG HIP BLADE F-SERIES - 5MM PKG, BARREL BUR, 6 FLUTE, LEFT HELIX F-SERIES-5.5MM PKG., ANGLED TOMCAT SHAVER BLADE F - SERIES - 4MM XL PKG., ANGLED AGG. PLUS SHAVER BLADE F - SERIES - 5MM PKG.,, SLAP BUR, 6 FLUTE F-SERIES - 4MM PKG., ANGLED AGG. PLUS SHAVER BLADE F - SERIES - 4MM PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4MM PKG., BARREL BUR, 12 FLUTE F - SERIES - 5.5MM PKG., AGG. PLUS SHAVER BLADE, INJECTION F-SERIES - 3.5MM PKG., RESECTOR LONG HIP CUTTER F-SERIES - 5MM PKG., AUGER BUR F- SERIES - 5MM PKG., EGG BUR, 6 FLUTE F - SERIES - 5.5MM PKG., ANGLED TOMCAT SHAVER BLADE F-SERIES - 4.5MM PKG., AGG. PLUS SHAVER BLADE, SMALL JOINT, F - SERIES - 2.5MM PKG., COUGAR SHAVER BLADE, F-SERIES - 4MM PKG., TOMCAT SHAVER BLADE, F - SERIES - 5MM PKG., ROUND BUR, 6 FLUTE F - SERIES - 5.5MM PKG., ROUND BUR, 12 FLUTE F - SERIES - 5MM PKG., UNHOODED ROUND BUR, 6 FLUTE F-SERIES - 4MM PKG., ANGLED TOMCAT SHAVER BLADE F - SERIES - 5MM PKG., BARREL BUR, 12 FLUTE F - SERIES - 5MM PKG., TOMCAT SHAVER BLADE, F - SERIES - 4MM PKG., XL ANGLED TOMCAT LONG HIP BLADE F-SERIES -4MM PKG., HOODED ABRASION BUR, SMALL JOINT F - SERIES - 2MM PKG., TOMCAT SHAVER BLADE, INJECTION F-SERIES - 3.5MM PKG., ROUND BUR, 6 FLUTE F - SERIES - 5MM PKG., ANGLED AGG. PLUS SHAVER BLADE F - SERIES - 4.5MM PKG., BARREL BUR, LEFT HELIX, 12 FLUTE, F-SERIES - 5.5MM PKG., ANGLED RESECTOR SHAVER BLADE F - SERIES - 5MM PKG., PARALLELPORTAL CUTTER, DOUBLE BEND AGG. PLUS 4MM, BOX OF 5 PKG, XL (LONG HIP), PEAR BUR 8 FLUTE, F-SERIES, 5.5MM PKG., BARREL BUR, 12 FLUTE F - SERIES - 4MM PKG., SLOTTED WHISKER SHAVER BLADE, F - SERIES - 4MM PKG., PARALLELPORTAL CUTTER, SINGLE BEND TOMCAT 3.5MM, BOX OF 5 PKG., RESECTOR SHAVER BLADE, F-SERIES - 3.5MM PKG., ROUND BUR, 12 FLUTE F-SERIES - 4MM PKG., TOMCAT LONG HIP BLADE F -SERIES - 4MM PKG., UNHOODED BARREL BUR, 6 FLUTE F - SERIES - 4MM PKG., PARALLELPORTAL CUTTER, SINGLE BEND TOMCAT 4MM, BOX OF 5 PKG., END CUTTER SHAVER BLADE, F - SERIES - 5MM PKG., PARALLELPORTAL CUTTER, SINGLE BEND AGG. PLUS 3.5MM, BOX OF 5 PKG., FULL RADIUS SHAVER BLADE, SMALL JOINT, F - SERIES - 3.5MM PKG., AGG. PLUS LONG HIP BLADE F-SERIES - 4MM PKG., COUGAR SHAVER BLADE, F-SERIES - 3.5MM PKG., TOMCAT SHAVER BLADE, SMALL JOINT, F-SERIES - 3.5MM PKG., ROUND BUR, 6 FLUTE F-SERIES - 4MM PKG., PARALLELPORTAL CUTTER, SINGLE BEND RESECTOR 3.5MM, BOX OF 5 PKG., DOUBLE BITE SHAVER BLADE3, S - SERIES - 4MM PKG., RESECTOR SHAVER BLADE, F - SERIES - 5.5MM PKG., TRUE END SHAVER BLADE, F - SERIES - 4MM

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)