BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASSY PKG TWINLOOP PEEK 3.5MM W/ONE NO. 2 FORCE FIBER

    Reg #: 2648045 · FEI: 2648045 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    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

    Regulatory Submissions

    510(k) Number
    K070882

    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
    Staple, Fixation, Bone JDR
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    ASSY PKG TWINLOOP PEEK 3.5MM W/ONE NO. 2 FORCE FIBER ASSY., PKG., 3.5MM PEEK TWINLOOP FLEX SE SINGLE STRAND ASSY PKG TWINLOOP SE PEEK 3.5MM W/ONE NO.2 FORCE FIBER ASSY PKG TWINLOOP SE PEEK 3.5MM W/TWO NO. 2 FORCE FIBER ASSY., PKG., 3.5MM PEEK TWINLOOP FLEX SE DOUBLE STRAND ASSY., PKG 3.5MM PEEK TWINLOOK FLEX SINGLE STRAND

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)