BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sterile Surgical Needles

    Reg #: 2953359 · FEI: 3000215205 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    60
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    2953359
    FEI Number
    3000215205
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2311 Lincoln Ave
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    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, Suturing, Disposable GAB

    Proprietary Names

    Sterile Surgical Needles Quattro Suture Needle MENISCAL REPAIR NEEDLE 10 EA Yellow Needle Counter Magnet/Foam Block 20-40 Count w/ Blade Remover 10 Count Foam Block Clear Top 30 Count Magnet Foam Block/Magnet 40 Count Blank Double Magnet 60 Count 1/2 Foam Block 20 Count Needle Counter ½ Magnet ½ Foam Block 40-80 Count with Blade Remover Needle Counter Foam Block/ Magnet 10 Count Double 30 Count Magnet/Single Foam Block 40 Count w/ Blade Remover Clear Suture Bag w/ adhesive 1/2 Magnet 1/2 Foam Block 20-40 Count w/ Blade Remover Syringe Cup Needle Counter w/ Blade Remover, Yellow Magnet/Foam Block 40-80 Count 1/2 Foam Strips 1/2 Black Magnet 30-60 Count w/ Blade Remover Single Magnet 10-20 Count Needle Counter Large 10 Count 1/2 Adhesive 1/2 Foam Block 1/2 Mag 1/2 Adhesive 10 Count Double Magnetic Strips 60 Count Suture Bag 8x10 Double Magnet 60 Count (Deep Box) Blade Remover Double 60 Count Magnet Adhesive/Foam Block 10 Count ½ Magnet ½ Foam Strips 80 Count with Blade Remover Magnet/Foam Block 20-40 Count. Private Labeled ROI(ROI# 236172) Adhesive/Foam Block 20-40 Count Magnet/Foam Strips 30-60 Count Clear Top 10 Count Magnet Clear Suture Bag w/ adhesive - Large Double Magnet White Double Magnet w/Blade Remover 30 Count Magnet/Foam Block 20-40 Count Foam Strip/Magnet 40 Count Blade Remover Magnet/Foam Strips 60-120 Count Double Magnet 60-120 Count ½ Foam Block ½ Adhesive 40-80 Count with Blade Remover Double Foam Block 40-80 Count Double Magnet 20-40 Count Single Magnet 30 Count Needle Counter 1/2 Magnet 1/2 Foam Block 40-80 Count Private Labeled 70931 Needle Counter- Double Blank Magnets w/ Blade Remover - Lifecell Needle Counter Large 10 Count 1/2 Magnet 1/2 Foam Block Blank Double Magnet Small Double Magnet w/o Numbers Double Foam Block 80-160 Count Foam Strip/Adhesive Needle Counter 1/2 Adhesive 1/2 Foam Strips w/ Slits 1/2 Foam Strips 1/2 15 Count Magnet Needle Counter 1/2 Magnet/ 1/2 Foam Block 40-80 Ct. Private Labeled for ROI(ROI# 236173) Double Magnet 30-60 Count Double Foam Strips 60-120 Count Adhesive/Foam 20-40 Count Safety Stop w/Plastic Box Temp. Sharps Holder Introducer Needle NDL16-10, 16g needle 10" long Magnet/Foam Strips 30-60 Count. Private Labeled for ROI(ROI# 236170) Introducer Needle NDL16-6, 16g needle 6" long Introducer Needle NDL16-8, 16g needle 8" long Introducer Needle NDL16-4, 16g needle 4" long Introducer Needle TUN13-10, 13g tunneler 10" long

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)