BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Knotilus+

    Reg #: 2649614 · FEI: 2649614 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Baxter Healthcare of Puerto Rico LLC
    Registration Number
    2649614
    FEI Number
    2649614
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    RD. 721, KM. 0.3
    City
    AIBONITO
    State
    PR
    ZIP
    00705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232683

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC

    Proprietary Names

    Knotilus+

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)