BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Isomedix Operations Inc.

    Reg #: 2032112 · FEI: 3003076831 · Expires 2026
    View on FDA
    Products
    137
    Proprietary Names
    99
    Establishment Types
    2
    Classifications
    136

    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    2032112
    FEI Number
    3003076831
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7685 ST.ANDREWS AVE.
    City
    SAN DIEGO
    State
    CA
    ZIP
    92154
    Country
    US

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    9072619
    Address
    5960 Heisley Road, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Catheter, Recording, Electrode, Reprocessed NLH
    Separator, Automated, Blood Cell, Diagnostic GKT
    Stethoscope, Esophageal BZW
    Tube, Tracheostomy (W/Wo Connector) BTO
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT
    Needle, Acupuncture, Single Use MQX
    Set, Administration, Intravascular FPA
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Reprocessed Intravascular Ultrasound Catheter OWQ
    Continuous Measurement Thermometer FLL
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Scalpel, One-Piece GDX
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    System, X-Ray, Tomography, Computed JAK
    Injector And Syringe, Angiographic DXT
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Instrument, Ultrasonic Surgical LFL
    Catheter, Intracardiac Mapping, High-Density, Reprocessed NLG
    System, Surgical, Computer Controlled Instrument NAY
    Handpiece, Belt And/Or Gear Driven, Dental EFA
    Catheter, Urological KOD
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Catheter, Intravascular, Diagnostic DQO
    Needle, Hypodermic, Single Lumen FMI
    Introducer, Catheter DYB
    System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
    Drape, Surgical, Exempt PUI
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
    Accessories, Blood Circuit, Hemodialysis KOC
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Brush, Scrub, Operating-Room GEC
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Catheter, Continuous Flush KRA
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Component, Traction, Invasive JEC
    Catheter, Straight EZD
    Cardiac Ablation Percutaneous Catheter LPB
    Apparatus, Exhaust, Surgical FYD
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Drape, Surgical, Antimicrobial KKX
    Tubing, Fluid Delivery FPK
    Warmer, Thermal, Infusion Fluid LGZ
    Staple, Implantable GDW
    Susceptibility Test Discs, Antimicrobial JTN
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Stapler, Surgical GAG
    Catheter, Urethral GBM
    Device, Vascular, For Promoting Embolization KRD
    OPE
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter And Tip, Suction JOL
    Oximeter DQA
    Tubes, Gastrointestinal (And Accessories) KNT
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Trocar, Reprocessed NMK
    Monitor, Breathing Frequency BZQ
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Catheter, Retention Type, Balloon EZL
    Pump, Infusion FRN
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Stopcock, I.V. Set FMG
    Catheter, Percutaneous DQY
    Set, I.V. Fluid Transfer LHI
    Administrations Sets With Neuraxial Connectors PWH
    Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
    Catheter, Ultrasound, Intravascular OBJ
    Catheter, Intracardiac Mapping, High-Density Array MTD
    Surgeon'S Gloves KGO
    Reprocessed Catheter Introducer PNE
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Counter, Differential Cell GKZ
    Apparatus, Autotransfusion CAC
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Stethoscope, Esophageal, With Electrical Conductors BZT
    Catheter, Intravascular Occluding, Temporary MJN
    Urinometer, Mechanical EXR
    Powered Laser Surgical Instrument GEX
    Device, Monitoring, Intracranial Pressure GWM
    Tubing, Noninvasive GAZ
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Probe, Thermodilution KRB
    External Cerebrospinal Fluid (Csf) Diversion PCB
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Laparoscope, General & Plastic Surgery GCJ
    Control, Hemoglobin GGM
    Accessories, Catheter KGZ
    Neurological Stereotaxic Instrument HAW
    Pump, Infusion, Pca MEA
    Support, Breathing Tube JAY
    System, Processing For Frozen Blood KSW
    Transducer, Blood-Pressure, Extravascular DRS
    Accessories, Catheter, G-U KNY
    Mesh, Surgical, Polymeric FTL
    Syringe, Piston FMF
    Catheter, Ventricular HCA
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Shunt, Central Nervous System And Components JXG
    Device, Warming. Blood And Plasma KZL
    Port & Catheter, Implanted, Subcutaneous, Intraperitoneal LLD
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Cable, Electrode IKD
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Spinal Vertebral Body Replacement Device MQP
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Bronchoscope (Flexible Or Rigid) EOQ
    Accessories, Pump, Infusion MRZ
    Electrocautery, Gynecologic (And Accessories) HGI
    Nebulizer (Direct Patient Interface) CAF
    Electrode, Pacemaker, Temporary LDF
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Resuscitator, Manual, Non Self-Inflating NHK
    Tube, Aspirating, Flexible, Connecting BYY
    Dispenser, Liquid Medication KYX
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL
    Urinary Drainage Collection Kit PPG
    Oximeter, Ear DPZ
    Connector, Airway (Extension) BZA
    Oximeter, Reprocessed NLF
    Catheters, Suction, Tracheobronchial BSY
    Tube Tracheostomy And Tube Cuff JOH
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Azo Dye, Calcium CJY
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    System, Thermal Regulating DWJ
    Computer, Diagnostic, Programmable DQK
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass DTW
    Kit, Surgical Instrument, Disposable KDD

    Proprietary Names

    Innovative7777 (SDA) - Reprocessed Diagnostic Electrophysiology Catheter Haemonetics2300 (SDA) - MCS+ Carefusion (SDA) - Set, administration, intravascular Innovative7777 (SDA) - Reprocessed Diagnostic Ultrasound Catheter StrykerSustainability (SDA) - Reprocessed Electrophysiology Catheters Jabil3944 (SDA) - HAND CONTROLLER KIT, CARTON, US, ATX-ACIST Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, US, DEHP FREE TUBING, STERILIZED Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, COEX, STERILIZED Carefusion5709 (SDA) - Alaris Extension Set- Ethicon (SDA,GP) - Instrument, Ultrasonic Surgical Innovative7777 (SDA) - Reprocessed Mapping Catheter Sensor Enabled Intuitive5779 (SDA,GP) - Si Harmonic ACE Insert StrykerSustainability6623 (SDA) - Reprocessed Intravascular Ultrasound Catheter StrykerSustainability (SDA) - Reprocessed External Fixation Devices StrykerSustainability (SDA) - Reprocessed Intravascular Ultrasound Catheter StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Cable Intuitive5779 (SDA,GP) - IS4200 Arm 4 Proximal Drape Protech3048 (GP) - 7894-6 - LEVO STERILE CERVICAL DRAPE W/WINDOW 6CS Protech3048 (GP) - 6855AUD-6 - HANA ANTERIOR HIP UPPER STERILE DRAPE, 6 StrykerSustainability6623 (SDA) - Reprocessed Electrode Recording Catheter Innovative7777 (SDA) - Reprocessed AcuNav Diagnostic Ultrasound Catheter Innovative7777 (SDA) - Reprocessed Mapping Catheter Ethicon (SDA,GP) - Staple, Implantable Ethicon (SDA) - Electrosurgical, Cutting & Coagulation & Accessories Ethicon (SDA,GP) - Surgical Stapler Innovative7777 (SDA) - Reprocessed Transseptal Needle StrykerSustainability6623 (SDA) - Reprocessed Catheter and Cable Carefusion5709 (SDA) - MedSystem III Infusion Set Haemonetics (SDA) - PCS Innovative7777 (SDA) - Reprocessed Steerable Introducer Haemonetics (SDA) - CELL SAVER Haemonetics (SDA) - CELL SAVER ELITE Medtronic4423 (SDA) - Becker External Drainage and Monitoring System Haemonetics (SDA) - MCS+ Innovative7777 (SDA) - Reprocessed Electrophysiology Catheter StrykerSustainability6623 (SDA) - Reprocessed EP Catheter and Cable Medtronic4423 (SDA) - DUET External Drainage And Monitoring System Haemonetics (SDA) - CYMBAL, MCS+ Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 60 Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Curved-Tip Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 45 Intuitive_5779 (SDA,GP) - Stapler SureForm™ 45 Straight-Tip Intuitive_5779 (SDA,GP) - Stapler SureForm™ 60 Instrument Intuitive_5779 (SDA,GP) - Stapler Reload SureForm™ 45 (Grey) Intuitive_5779 (SDA,GP) - Xi Stapler 30 Reload Intuitive5779 (SDA,GP) - Xi Column Drape Intuitive5779 (SDA,GP) - Xi Instrument Arm Drape Intuitive5779 (SDA,GP) - Xi Single-Site Cannula Seal Intuitive5779 (SDA,GP) - Xi Single-Site Port Intuitive5779 (SDA,GP) - Xi Single Site Bipolar Maryland StrykerSustainability6623 (SDA) -Reprocessed Electrode Recording Catheter Intuitive_5779 (SDA,GP) - Xi Vessel Sealer Extend Nellcor9703 (CH2) - Covidien LLC Intuitive5779 (SDA,GP) - Xi Harmonic ACE Jabil3944 (SDA) - PREMIUM HAND CONTROL KIT, HTP, STERILIZED Intuitive5779 (SDA,GP) - Stapler Sheath Intuitive5779 (SDA,GP) - MCS Tip Cover Medtronic4423 (SDA) - Exacta External Drainage and Monitoring System Intuitive5779 (GP,SDA) - Xi Stapler 45 Reload Intuitive5779 (SDA,GP) - Xi 8mm Synchroseal Intuitive_5779 (SDA,GP) - 8mm Stapler Ethicon (SDA,GP) - ETHICON™ 4000 Medtronic4423 (SDA) - PS MEDICAL CSF-LUMBOPERITONEAL SHU Haemonetics (SDA) - ACP215 Haemonetics (SDA) - RIS StrykerSustainability (SDA) - Reprocessed EP Catheter Medtronic4423 (SDA) - PS MEDICAL CSF-FLOW CONTROL VALVE StrykerSustainability6623 (SDA) - Electrode Cable Innovative7777 (SDA) - CABLE, ELECTRODE CodanUS3940 (SDA) - BBG Carefusion5709 (SDA) - Alaris Syringe Module Syringe Administration Set BiosenseWebster3941 (SDA,GP) - Interface Cable Ethicon (SDA,GP) - ETHICONTM 4000 45mm Stapler Intuitive5779 (SDA,GP) - 19G Biopsy Needle Intuitive5779 (SDA,GP) - Vision Probe Adapter Intuitive5779 (SDA,GP) - 21G Biopsy Needle Intuitive5779 (SDA,GP) - 23GBiopsy Needle Intuitive5779 (SDA,GP) - Swivel Connector StrykerSustainability (SDA) - Reprocessed EP Catheters Intuitive_5779 (SDA,GP) - SP Instrument Sheath Intuitive_5779 (SDA,GP) - SP Camera Instrument Sheath Intuitive_5779 (SDA,GP) - SP Monopolar Scissors Tip Innovative7777 (SDA) - Reprocessed Mapping Diagnostic Electrophysiology Catheter Ethicon (SDA,GP) - Electrosurgical, Cutting & Coagulation & Accessories Intuitive5779 (SDA,GP) - Xi Single Site Fenestrated Bipolar Forceps Innovative7777 (SDA) - Reprocessed Intravascular Ultrasound Catheter Intuitive5779 (SDA,GP) - Si Cannula Seal Intuitive5779 (SDA) - Stapler Sheath Innovative7777 (SDA) - Reprocessed Catheter Introducer Medtronic4423 (SDA) - PS MEDICAL EXTERNAL DRAINAGE AND MONITORING VENTRICULAR CATHETER Medtronic4423 (SDA) - INTRACRANIAL PRESSURING MONITORING SYSTEM StrykerSustainability (SDA) - Reprocessed Ligasure Blunt Tip Laparoscopic Sealer/Divider Medtronic4423 (SDA) - PS MEDICAL EXACTA DRAINAGE SYSTEM Medtronic4423 (SDA) - BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Innovative7777 (SDA) - Reprocessed Cable StrykerSustainability6623 (SDA) - Reprocessed Catheter Introducer Medtronic4423 (SDA) - PS MEDICAL BIOGLIDE CSF Innovative7777 (SDA) -Reprocessed Diagnostic Electrophysiology Catheter Innovative7777 (SDA) - Reprocessed Catheter Connecting Cable

    Establishment Types

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