BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HYPO NEDL-PRO 19G X 2" 600/CA Portex Hypodermic Needle-Pro Device

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K923127

    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
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    HYPO NEDL-PRO 19G X 2" 600/CA Portex Hypodermic Needle-Pro Device HYPO NEEDLE PRO 25GX1.5 HYPO NEDL-PRO 18G X 1 1/2 HYPO NEDL-PRO 18G X 1 BULK(NEDL-PRO DEVICE) ** HYPO NEDL-PRO 20G X 1 HYPO NEDL-PRO 23G X 1 HYPO NEDL-PRO 21G X 1 1/2 HYPO NEDL-PRO LS 22Gx1 K923127 HYPO NEDL-PRO LS 21GX1.5 HYPO NEDL-PRO LS 25GX1 HYPO NEDL-PRO LS 21Gx1 HYPO NEDL-PRO LS 25GX5/8 19GX1.5 HYPO NEDL-PRO 19G X 2" 600/CA ELI LILLY OEM Portex Hypodermic Needle-Pro Device HYPO NEDL-PRO 22G X 1 1/2 HYPO NEDL-PRO LS 20Gx1.5 HYPO NEDL-PRO 22G X 1 HYPO NEDL-PRO LS 23GX1 HYPO NEDL-PRO 25G X 5/8 HYPO NEDL-PRO LS 20Gx1 HYPO NEDL-PRO 25G X 1 HYPO NEDL-PRO 19G X 1 NEEDLE PRO JANSSEN REPLACEMENT KIT + 200/CA Portex Hypodermic Needle-Pro Device HYPO NEDL-PRO 19G X 1 1/2 HYPO NEDL-PRO LS 22Gx1.5 BULK(NEDL-PRO S DEVICE) ** HYPO NEDL-PRO 20G X 1 1/2 HYPO NEDL-PRO 21G X 1 HYPO NEEDLE-PRO 19G X 1 1/2 HYPO NEEDLE-PRO 20G X 2" + 1500/CA Portex Hypodermic Needle-Pro Device HYPODERMIC NEEDLE PRO 21G X 2" (OTSUKA) 600/CA Portex Hypodermic Needle-Pro Device NEEDLE PRO JANSSEN REPLACEMENT KIT CE 200/CA Portex Hypodermic Needle-Pro Device Hypodermic Needle Pro 3mL LL Syringe & 21G X 1-1/2" ( Otsuka ) 400/CA Portex Hypodermic Needle-Pro Device HYPO NEDL-PRO 20G X 2" - JPKK 1500/CA Portex Hypodermic Needle-Pro Device NEEDLE PRO - JANSSEN 21X1" US ONLY 1500/CA Portex Hypodermic Needle-Pro Device NEEDLE PRO JANSSEN + 1,500/CA Portex Hypodermic Needle-Pro Device HYPODERMIC NEEDLE PRO 21G X 1-1/2" (OTSUKA) 800/CA Portex Hypodermic Needle-Pro Device HYPO NEDL-PRO 19G X 2 HYPODERMIC NEEDLE-PRO DEVICE WITH NEEDLE - 20G X 2" & 21G X 1" 900/CA Portex Hypodermic Needle-Pro Device NEEDLE PRO-JANSSEN REPLACEMENT KIT 21X1" 200/CA Portex Hypodermic Needle-Pro Device NEEDLE PRO-JANSSEN 2" US ONLY 1500/CA Portex Hypodermic Needle-Pro Device NEEDLE PRO-JANSSEN REPLACEMENT KIT 20G X 2" & 21GX1" 200/CA Portex Hypodermic Needle-Pro Device

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)