BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 MONOGLIDE

    Reg #: 2246552 · FEI: 2246552 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    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
    K031443

    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, Polyester GAS
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM

    Proprietary Names

    LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 MONOGLIDE LSISol6612 (PL) - RD QUICK LOAD SUTURE – 0 Polyester LSISol6612 (PL) - RD QUICK LOAD SUTURE – 0 MONOGLIDE LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 STRONGSORB

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)