BEUDAMED
    FDA Registration Active 🇺🇸 United States

    5MM X 32CM ASPIRATION NEEDLE TIP

    Reg #: 2648666 · FEI: 2648666 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER PUERTO RICO, LLC.
    Registration Number
    2648666
    FEI Number
    2648666
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    HWY. 3, KM. 131.2, LAS GUASIMAS IND. PARK
    City
    ARROYO
    State
    PR
    ZIP
    00714
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042457

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    System, Irrigation, Urological LJH

    Proprietary Names

    5MM X 32CM ASPIRATION NEEDLE TIP 10MM X 32CM STONE SCOOPER 5MM X 32CM POOL SUCTION TIP, METAL FINISH 2MM X 34CM REGULAR TIP WITH NO HOLES, METAL FINISH 5MM X 45CM REGULAR TIP, VENTED, METAL FINISH 5MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 5MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH FLEXIBLE LASER FIBER GUIDE, 32CM 3MM X 32CM REGULAR TIP, VENTED, METAL FINISH CORE HUMMER IRRIGATION CASSETTE 5MM X 32CM HYDRODISSECTION TIP, NON-REFLECTIVE FINISH PKG.SINUFLOW SUCTION/IRRIGATOR 5MM X 45CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 2 SPIKE GRAVITY FLOW TUBE SET, DISPOSABLE (10BX) 10MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH 5MM X 32CM NON-CONDUCTIVE TIP, VENTED STRYKEFLOW PS, DUAL SPIKE, 10FT OF TUBING (6BX) 2MM X 32CM REGULAR TIP WITH 2 HOLES, METAL FINISH 5MM X 32CM REGULAR TIP, VENTED, METAL FINISH 5MM X 32CM REGULAR TIP WITH NO HOLES, NON-REFLECTIVE FINISH 4 SPIKE GRAVITY FLOW TUBE SET, DISPOSABLE (10BX) 5MM X 24CM REGULAR TIP, VENTED, METAL FINISH ADAPTER FOR DAVOT NEZHAT/DORSEY SUCTION/IRRIGATION PROBES 3MM X 32CM REGULAR TIP, NON-VENTED, METAL FINISH 2MM X 32CM REGULAR TIP WITH 1 HOLE, METAL FINISH STRYKEFLOW2 WITHOUT TIP (6BX) AHTO SUCTION/IRRIGATION TUBE SET (6BX) AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX) 5MM X 28CM REGULAR TIP, VENTED, METAL FINISH 5MM X 32CM REGULAR TIP, NON-VENTED, METAL FINISH 10MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 5MM X 32CM HYDRODISSECTION TIP, METAL FINISH 5MM X 28CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH 10MM X 32CM POOL SUCTION TIP, METAL FINISH RIGID LASER FIBER GUIDE FLEXIBLE LASER FIBER GUIDE, 28CM AHTO SUCTION/IRRIGATION DUAL SPIKE TUBE SET STRYKEFLOW2 WITH DISPOSABLE TIP (6BX) STRYKEFLOW SINGLE SPIKE TUBING (6BX) 10MM X 32CM REGULAR TIP, VENTED, METAL FINISH DUAL IRRIGATION ADAPTER, DISPOSABLE (10BX)

    Establishment Types

    Manufacture Medical Device