BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sterigenics U.S., LLC

    Reg #: 2219920 · FEI: 2219920 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    80
    Establishment Types
    2
    Classifications
    30

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2219920
    FEI Number
    2219920
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    108 Lake Denmark Rd
    City
    Rockaway
    State
    NJ
    ZIP
    07866
    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
    Reherniation Reduction Device QES
    Clamp, Vascular DXC
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Capillary Blood Collection Device For Alternative Site Collection PRJ
    Tube, Tracheostomy (W/Wo Connector) BTO
    Mesh, Surgical, Polymeric FTL
    Implant, Endosseous, Root-Form DZE
    Tonometer, Manual HKY
    Wire, Guide, Catheter DQX
    Magnetic Surgical System PNL
    System, Suspension, Cell Culture KJF
    Laparoscope, General & Plastic Surgery GCJ
    Abutment, Implant, Dental, Endosseous NHA
    Infusion Pump, Drug Specific, Pharmacy-Filled QJY
    Alternate Controller Enabled Insulin Infusion Pump QFG
    Calculator, Drug Dose NDC
    Laparoscopic Single Port Access Device OTJ
    Thermometer, Clinical Color Change FQZ
    Electrode, Electrosurgical JOS
    Containment System, Laparoscopic Power Morcellation, With Instrument Port PMU
    Tube Tracheostomy And Tube Cuff JOH
    Bone Grafting Material, Animal Source NPM
    Bone Grafting Material, Synthetic LYC
    Clip, Iris Retractor HOC
    Pump, Infusion FRN
    Tissue Graft Of 6mm And Greater LXA
    Liner, Cavity, Calcium Hydroxide EJK
    System, Suction, Lipoplasty MUU
    Prosthesis, Intervertebral Disc MJO
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    NovaClips Greyhound Spring Clips Universal Plus Acessa Handpiece (previously known as Tulip RF Probe) PILLING Peak PlasmaBlade Plus DTF-13, TF-S, DTF-18, DTF-24, DTF-24b, DTF-31, 40990031, DTF-32, JSMDTF32, DTF-39, JSMDTF39, DTF-40, 4793.692, DTF-45, Ceruleau Peak PlsamaBlade Tonsil A2D, A8D, B1D, B2D, C3D, CV-B1, CV-B1/S, CV-B2, CV-B2/S, CV-B3, CV-B3/S, CV-L3, CV-L3/S, CV-L5, CV-L5/S, CV-L7, CV-L7/S, Olsen electrosurgical instruments and accessories ELECTROSURGICAL PENCIL Caiman TAP TAP II K862167 MINI TRACH II + 10/BX Portex Mini Tach II EM SA Implant System TYRX Absorbable Antibacterial Envelope Ocu-Film® + Tip Covers EM Provisional Attain Hybrid Guide Wire HG III ULTRA WIDE FIXTURE SYSTEM EXP-Pak¿ Access port for multiple instruments and/or cameras during minimally invasive abdominal laparospice surgery HIOSSEN IMPLANT SYSTEM ET III Nano-HA Fixture System IEC-BC Minor Surgery Bipolar Cable Sterile, Single-Use, (5 pcs) IEC-DJX Bipolar Cable, Sterile (10 pcs) IEC-BC/I Minor Surgery Bipolar Cable Sterile, Single-Use Intro Pkg Single Use Thermometers, Tempa-DOT,5122, 5125, 5532, 5538 Tempadot, Single use clinical thermometer Electrodes - Cynsure Ellman ELECTRODE, NEEDLE, 5 FR. 60CM NEUROENDOSCOPY ELECTRODE, BUTTON, 4 FR. ELECTRODE, COAGULATING BUTTON, 10 FR.,400 MM WL ELECTRODE, BUTTON, 3 FR. 3 FR., 260 MM WL ELECTRODE, COAGULATING BUTTON, 3 FR. ELECTRODE, COAGULATING BUTTON, 5 FR., 400 MM WL ETIV SA Dental Implants ET III BIO SA FIXTURE SYSTEM HT III SA FIXTURE SYSTEM A-Oss®BONE GRAFTING MATERIAL, ANIMAL SOURCE InTrack Inserts DentoGen Iris retractor, disposable Iris Expander Zinger™ Guidewire Cougar™ Guidewire ProVia™ Guidewire Thunder™ Guidewire Intuition™ Guidewire Procol Biologic Vascular Graft PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 9MM 2/CA Portex Griggs Percutaneous Blu Line Tra PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 8MM 2/CA Portex Griggs Percutaneous Blu Line Tra PORTEX GRIGGS PERCUTANEOUS DILATION BLU TRACHY KIT WITH DRUGS SIZE 7MM 2/CA Portex Griggs Percutaneous Blu Line Trac PORTEX GRIGGS PERCUTANEOUS DILATION BLU TRACHY KIT WITH DRUGS SIZE 9MM 2/CA Portex Griggs Percutaneous Blu Line Trac K060945 PORTEX GRIGGS PERCUTANEOUS DILATION BLUS TRACHY KIT WITH DRUGS SIZE 7MM 2/CA Portex Griggs Percutaneous Blu Line Tra PORTEX GRIGGS PERCUTANEOUS DILATION BLU TRACHY KIT WITH DRUGS SIZE 8MM 2/CA Portex Griggs Percutaneous Blu Line Trac ETIII SA Fixture System (D3.2) implant ETIII SA Fixture System (D3.2) Elliquence Bipolar Electrodes XEE401A, 4792.6912 EK Healing Abutment EK NH Implant EK SA Implant ULTRAPERC LOCAL INFILTRATION (SDD) W/DRUGS + 10/CA Portex UltraPerc Local Infiltration Tray Portex Ultraperc ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLU TUBE +2/CA Portex UltraPerc Singl ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLUS TUBE +2/CA Portex UltraPerc Sin ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLU TUBE +2/CA Portex UltraPerc Sing K041348 ULTRAPERC PERC S/S DILATION TRACHY KIT FOR 7, 8, 9MM TUBES, SOFT INTRODUCERS, 2/CA Portex UltraPerc Percutaneous T ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 7MM BLUS TUBE +2/CA Portex UltraPerc Sin ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 8MM BLU TUBE +2/CA Portex UltraPerc Sing ULTRAPERC PERCUTANEOUS SINGLE STAGE DILATION TRACHEOSTOMY PROCEDURE KIT WITH 9MM BLUS TUBE +2/CA Portex UltraPerc Sin ET II SA FIXTURE SYSTEM ET III SA ULTRA WIDE SYSTEM + (HEALING ABUTMENT) InTrack Jaw Inserts NanoGen GrafSet

    Establishment Types

    Manufacture Device in the United States for Export Only Sterilize Medical Device for Another Party (Contract Sterilizer)