BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Isomedix Operations Inc.

    Reg #: 3013820501 · FEI: 3013820501 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    29

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    Registration Details

    Registration Name
    Isomedix Operations Inc.
    Registration Number
    3013820501
    FEI Number
    3013820501
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2 Nucifora Blvd
    City
    Chester
    State
    NY
    ZIP
    10918
    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Injector And Syringe, Angiographic DXT
    Iodinated Contrast Media Transfer Tubing Set PQH
    Filler, Bone Void, Calcium Compound MQV
    Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair QNI
    Set, Administration, Intravascular FPA
    Wound Dressing With Animal-Derived Material(S) KGN
    Set, I.V. Fluid Transfer LHI
    Dressing, Wound, Drug FRO
    Barrier, Animal Source, Intraoral NPL
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Penile Implant Surgical Accessories QGA
    Mesh, Surgical FTM
    Tubing, Fluid Delivery FPK
    Bone Grafting Material, Animal Source NPM
    Sealant, Dural NQR
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Drape, Surgical, Antimicrobial KKX
    Dressing, Wound, Hydrophilic NAC
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen OLC
    Dressing, Wound, Occlusive NAD
    Spinal Vertebral Body Replacement Device MQP
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Barrier, Synthetic, Intraoral NPK
    Pipette, Diluting GGY
    Spinal Vertebral Body Replacement Device - Cervical PLR
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ

    Proprietary Names

    Nellcor9703 (CH2) - Covidien LLC Bayer1675 (CH2) - MEDRAD® Stellant FLEX 150 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1675 (CH2) - MEDRAD Stellant Single Syringe Tri-Pak with Spike Bayer1675 (CH2) - MEDRAD Stellant Single Syringe Tri-Pak with QFT Bayer1675 (CH2) - MEDRAD® Stellant FLEX 150 mL Sterile Disposable Syringe with Spike Bayer1675 (CH2) - MEDRAD Dual Check Valve Transfer Set for MR Bayer1675 (CH2) - Stellant Single Syringe Tri-Pak Kit with QFT Bayer1675 (CH2) - Stellant Single Syringe Tri-Pak Kit with SPK NexxtSpine14118 (CH2) - NEXXT MATRIXX; TrellOss-C SA Bayer (CH2) - 50cm Low Pressure Connector Tubing Bayer1675 (CH2) - MEDRAD® MRXperion Multi-Patient Syringe Kit Bayer1675 (CH2) - MEDRAD Stellant 250cm Single Patient Disposable NexxtSpine14118 (CH2) - NEXXT MATRIXX®; TrellOss-A SA NexxtSpine14118 (CH2) - NEXXT MATRIXX; TrellOss Integra2421 (CH2) - OsteoStrux Osteo-conductive Scaffold-Putty Integra2421 (CH2) - Collage Osteo-conductive Scaffold-Putty Integra2421 (CH2) - OS Osteo-conductive Scaffold-Putty NexxtSpine14118 (CH2) - NEXXT MATRIXX NexxtSpine14118 (CH2) - Nexxt Matrixx; TrellOss-TC

    Establishment Types

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