BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Y-KNOT RC ANCHOR WITH TAPE,ONE 2MM BLUE HI-FI TAPE, ONE NO.2 (5 METRIC) BLUE/BLACK HI-FI SUTURE

    Reg #: 1018470 · FEI: 1018470 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1018470
    FEI Number
    1018470
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2971 Olympic Industrial Dr SE Ste 116
    City
    Atlanta
    State
    GA
    ZIP
    30339
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131035

    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
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    Y-KNOT RC ANCHOR WITH TAPE,ONE 2MM BLUE HI-FI TAPE, ONE NO.2 (5 METRIC) BLUE/BLACK HI-FI SUTURE Y-KNOT RC ANCHOR WITH TAPE, ONE 2MM WHITE/BLACK HI-FI TAPE, ONE NO.2 (5 METRIC) BLUE HI-FI SUTURE Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR WITH TWO 2 (5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 BLUE) Y-KNOT FLEX HIP 1.8MM ALL SUTURE ANCHOR WITH TWO 2 (5 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 BLUE) Y-Knot RC with Needles All-Suture Anchor with/ Three No. 2 (5 metric) HiFi Sutures Y-Knot RC with Needles All-Suture Anchor, with/ Two No. 2 (5 metric) HiFi Sutures Y-KNOT RC ANCHORWITH TAPE, ONE 2MM BLUE HI-FI TAPE, ONE NO.2 (5 METRIC) BLUE HI-FI SUTURE Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR WITH TWO 2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK AND 1 WHITE/BLUE)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)