BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 25mm Angled (ASTM F138)

    Reg #: 1649518 · FEI: 3001236277 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    1649518
    FEI Number
    3001236277
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3125 Wichita Court
    City
    Fort Worth
    State
    TX
    ZIP
    76140
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112675

    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
    Pin, Fixation, Smooth HTY

    Proprietary Names

    ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 25mm Angled (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 35mm Angled (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 35mm Straight (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 22mm Angled (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 30mm Angled (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 19mm Straight (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 25mm Straight (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 19mm Angled (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 22mm Straight (ASTM F138) ARROW-LOK Hybrid: Dia. 2.5-3.5mm / Length 30mm Straight (ASTM F138)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)