BEUDAMED
    FDA Registration Active 🇺🇸 United States

    17 ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3002907620
    FEI Number
    3002907620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1700 College Blvd.
    City
    West Memphis
    State
    AR
    ZIP
    72301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093146

    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
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    17 ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point 18 ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point 19 UTW, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point 19 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point 18 ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point 17 ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point 22 UTW, 125mm Always-On Tip Tracked Biopsy Needle, Trocar Point 17 ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point 17 ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point 17 ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point 19 UTW, 45mm Always-On Tip Tracked Biopsy Needle, Chiba Point 19 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point 18 ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point 19 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point 19 UTW, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point 17 ga LG, 123mm Always-On Tip Tracked Biopsy Needle, Chiba Point 17 ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point 17 ga, 45mm Always-On Tip Tracked Biopsy Needle, Chiba Point SPiN Perc Localization Needle 19ga x 105mm with 2cm marking zone SPiN Perc Localization Needle 19ga x 105mm with 1cm marking zone

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)