BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OptiMesh 1500DS Catalog# 551-2505

    Reg #: 1423662 · FEI: 3000215273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1423662
    FEI Number
    3000215273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1003 Lakeside Drive
    City
    Gurnee
    State
    IL
    ZIP
    60031
    Country
    US

    Regulatory Submissions

    510(k) Number
    K014200

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Mesh, Surgical, Metal EZX

    Proprietary Names

    OptiMesh 1500DS Catalog# 551-2505 OptiMesh 1500DS Catalog# 551-2205 OptiMesh 1500S Catalog# 300-2002 OptiMesh 1500E Catalog# 330-2705 OptiMesh 1500E Catalog# 330-2505 OptiMesh 1500S Catalog# 300-2702 OptiMesh 1500E Catalog# 330-1805 OptiMesh 1500DS Catalog# 551-1805 OptiMesh 1500S Catalog# 300-2302 OptiMesh 1500E Catalog# 330-2205 OptiMesh 1500DS Catalog# 551-2005 OptiMesh 1500E Catalog# 330-2005 1500E OptiMesh, #¿s 330-1805, 330-2005, 330-2205, 330-2505, 330-2705 500E OptiMesh, #¿s 630-1806, 630-2306 1500DS OptiMesh, #¿s 551-1805, 551-2005, 551-2205, 551-2505 1500S OptiMesh, #¿s 300-2002, 300-2302, 300-2702

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)