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    FDA Registration Active 🇺🇸 United States

    Smith&Nephew3754 (NR) - EndoButton CL-BTB – 55mm, Fixation Button with 55mm Continuous Suture Loop

    Reg #: 1220477 · FEI: 1220477 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1220477
    FEI Number
    1220477
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    435 WHITNEY ST.
    City
    Northboro
    State
    MA
    ZIP
    01532
    Country
    US

    Regulatory Submissions

    510(k) Number
    K980155

    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
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Smith&Nephew3754 (NR) - EndoButton CL-BTB – 55mm, Fixation Button with 55mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 40mm, Fixation Button with 40mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 45mm, Fixation Button with 45mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 20mm, Fixation Button with 20mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 50mm, Fixation Button with 50mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 25mm, Fixation Button with 25mm Continuous Suture Loop Smith&Nephew3754(NR) - EndoButton CL-BTB – 30mm, Fixation Button with 30mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 60mm, Fixation Button with 60mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 60mm, Fixation Button with 60mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 35mm, Fixation Button with 35mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB Fixation Button with 15mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 25mm, Fixation Button with 25mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 15mm, Fixation Button with 15mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 35mm, Fixation Button with 35mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 55mm, Fixation Button with 55mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 50mm, Fixation Button with 50mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 20mm, Fixation Button with 20mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 30mm, Fixation Button with 30mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL – 45mm, Fixation Button with 45mm Continuous Suture Loop Smith&Nephew3754 (NR) - EndoButton CL-BTB – 40mm, Fixation Button with 40mm Continuous Suture Loop

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)