BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LSISol6612 (PL) - C1 Depth Limiter

    Reg #: 2246552 · FEI: 2246552 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    2246552
    FEI Number
    2246552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3459 SOUTH CLINTON AVE.
    City
    S Plainfield
    State
    NJ
    ZIP
    07080
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100593

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Laparoscope, General & Plastic Surgery GCJ
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Instrument, Ligature Passing And Knot Tying HCF

    Proprietary Names

    LSISol6612 (PL) - C1 Depth Limiter LSISol6612 (PL) - COR-SUTURE QUICK LOAD - 2-0 Polyester, White, Non-Absorbable LSISol6612 (PL) - RD180 5mm – THE RUNNING DEVICE LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 Polypropylene LSISol6612 (PL) - C1 Device (Straight Shaft) LSISol6612 (PL) - COR-KNOT MIS DEVICE KIT LSISol6612 (PL)- RD QUICK LOAD SUTURE – 2-0 Polyester LSISol6612 (PL) - COR-KNOT MINI DEVICE KIT LSISol6612 (PL) - COR-KNOT MINI COMBO KIT LSISol6612 (PL)- COR-SUTURE QUICK LOAD - 3-0 Polypropylene, Non-Absorbable LSISol6612 (PL)- TK QUICK LOAD LSISol6612 (PL) - RD180 10mm – THE RUNNING DEVICE LSISol6612 (PL) - TK Ti-KNOT DEVICE LSISol6612 (PL) - C1 Device LSISol6612 (PL) - COR-KNOT MIS COMBO KIT LSISol6612 (PL) - RD180 SP – THE RUNNING DEVICE LSISol6612 (PL) - COR-SUTURE QUICK LOAD - 2-0 Polyester, Green, Non-Absorbable LSISol6612 (PL) - COR-KNOT QUICK LOAD SINGLES LSISol6612 (PL) - INTRA-KNOT QUICK LOAD LSISol6612 (PL) - COR-KNOT QUICK LOAD 6-POUCH

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)