BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISOMEDIX OPERATIONS INC.

    Reg #: 1319660 · FEI: 1000136478 · Expires 2026
    View on FDA
    Products
    114
    Proprietary Names
    171
    Establishment Types
    2
    Classifications
    114

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    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1319660
    FEI Number
    1000136478
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    23 ELIZABETH DR.
    City
    CHESTER
    State
    NY
    ZIP
    10918
    Country
    US

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Splint, Intranasal Septal LYA
    Barrier, Animal Source, Intraoral NPL
    Clamp, Vascular DXC
    Cutter, Surgical FZT
    Grinder, Tissue LEC
    Instrument, Diamond, Dental DZP
    Orthopedic Manual Surgical Instrument LXH
    Set, I.V. Fluid Transfer LHI
    Microtools, Assisted Reproduction (Pipettes) MQH
    Sponge, Ophthalmic HOZ
    Prosthesis, Intervertebral Disc MJO
    Ear Wick KCN
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Penile Implant Surgical Accessories QGA
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Filler, Bone Void, Non-Osteoinduction MBS
    Microtools, Assisted Reproduction (Pipettes), Exempt PUC
    Needle, Aspiration And Injection, Disposable GAA
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Container, Specimen, Sterile FMH
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Neurosurgical Paddie HBA
    Marker, Skin FZZ
    Marker, Radiographic, Implantable NEU
    Wound Dressing With Animal-Derived Material(S) KGN
    Tape And Bandage, Adhesive KGX
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Thoracolumbosacral Pedicle Screw System NKB
    Filler, Bone Void, Calcium Compound MQV
    Implant, Eye Valve KYF
    Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal MXY
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Bone Grafting Material, Animal Source NPM
    Knife, Ophthalmic HNN
    Fiber, Medical, Absorbent FRL
    Cuff, Nerve JXI
    Dura Substitute GXQ
    Set, Administration, Intravascular FPA
    Screw, Fixation, Bone HWC
    Forceps, General & Plastic Surgery GEN
    Unit, Cautery, Thermal, Battery-Powered HQP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Mesh, Surgical FTM
    Infusion Safety Management Software PHC
    Pump, Infusion FRN
    Apparatus, Hemoperfusion, Sorbent FLD
    Plate, Fixation, Bone HRS
    Instrument, Ligature Passing And Knot Tying HCF
    Intraocular Pressure Lowering Implant OGO
    Motor, Surgical Instrument, Ac-Powered GEY
    Radiographic Protective Glove IWP
    Cannula, Ophthalmic HMX
    Prosthesis, Posterior Spinal Elements QWK
    Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief NHI
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Flask, Tissue Culture KJA
    Unit, Phacofragmentation HQC
    Vitrectomy, Instrument Cutter MLZ
    Apparatus, Cautery, Radiofrequency, Ac-Powered HQR
    Catheter, Irrigation GBX
    Lavage, Jet FQH
    Dressing, Wound, Drug FRO
    Instrument, Biopsy KNW
    System, Suspension, Cell Culture KJF
    Plug, Punctum LZU
    Electrode, Electrosurgical JOS
    Spinner System, Cell Culture KJE
    Electrode, Needle GXZ
    Pin, Fixation, Smooth HTY
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Bone Grafting Material, Human Source NUN
    Point, Abrasive EHL
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Endoscopic Tissue Approximation Device OCW
    Syringe, Piston FMF
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Computer, Diagnostic, Programmable DQK
    Computer, Blood-Pressure DSK
    Bone Wedge PLF
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bone Grafting Material, Synthetic LYC
    Negative Pressure Wound Therapy Non-Powered Suction Apparatus OKO
    Gauze/Sponge, Internal EFQ
    Bottle, Roller, Tissue Culture KJC
    Stabilizer, Heart MWS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Spinner, Flask KJD
    Tube, Aspirating, Flexible, Connecting BYY
    Tourniquet, Nonpneumatic GAX
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    File, Pulp Canal, Endodontic EKS
    Staple, Fixation, Bone JDR
    Jelly, Lubricating, For Transurethral Surgical Instrument FHX
    Bur, Dental EJL
    Dish, Tissue Culture KIZ
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Neurosurgical Nerve Locator PDQ
    Immunoglobulin G (Igg) Infusion System PKP
    Cannula, Trocar, Ophthalmic NGY
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Gauze / Sponge,Nonresorbable For External Use NAB
    Pump, Infusion, Pca MEA
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Instruments, Surgical, Cardiovascular DWS
    Knife, Orthopedic HTS
    Apparatus, Electrosurgical HAM
    Cystotome HNY
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    CookVandergrift (CH1,WH*) - Blastomere Aspiration Pipette BVI1689 (CH1) - Ultracell PVA Eye Spears BVI1689 (CH1) - Ultracell® Cataract Kit BVI1689 (CH1) - Ultracell Eye Wick BVI1689 (CH1) - Ultracell Cellulose Eye Spears BVI1689 (CH1) - Ultracell Fluid Collection Bag With Wick BVI1689 (CH1) - Ultracell Instrument Wipes Lifenet2559 (CH1,WH*,LN*) - Arthrex SpeedFLEX Implant Lifenet2559 (CH1,WH*) - ReadiGraft BLX Putty CookVandergrift (CH1,WH*) - Embryo Biopsy Pipette Merit1383 (SN) - ShortStop Temporary Sharps Holder Merit1383 (TM) - BackStop Plus Closed Waste Basin Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115 BVI1689 (CH1,EP1) - Retrobulbar BVI1689 (EP1, CH1) - Peribulbar Clearside6394 (MN,SP) - SCS Microinjector Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM Pretium1202 (WT) - Leakbuster PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag with Procedure Pack (Ref 622281) PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280) Merit1383 (SN) - Cultura Saliva Self Collection Kit PFMMedical6614 (TM) - ASEPT 2,000mL Drainage Bag (Ref M7058) PFMMedical (TM) - ASEPT 2,000mL Drainage Bag with Procedure Pack (Ref M7060) CorningME1979 (CH1) - Corning Closed Systems individually wrapped centrifuge tubes and accessories BD4590 (SP) - BD Vacutainer® No Additive (Z) Plus Tubes Kirwan2512 (CH1,NR) - Bipolar Disposable Cord Ensera7760 (SP) - ClarifEye Markers WolfX-Ray11781 (SP) - Steritatt Merit1383 (NT,SN) - StayFIX Fixation Device PFMMedical6614 (TM) - ASEPT Drainage Catheter Dressing Kit (Ref M7041) Ursel11054 (MN) - TRU-FIX Catheter Fixation Kit Insulet5490 (NR) - PodPals Adhesive Overlay Insulet5490 (NR) - Adhesive Overlay Premia (CH1) - ProMIS Fixation System NisshaMedical11704 (CH1,NR) - UltraFix NisshaMedical11704 (CH1,NR) - UltraFix MiniMite PDI2826 (CH1) - Hygea Sterile Saline Wipe Tyber6592 (WH,CH1) - Screw, Fixation, Bone Tyber6592 (WH,CH1) - Screw, Fixation, bone Kirwan2512 (CH1, NR) - Kirwan Monopolar Forceps Kirwan2512 (CH1,NR) - Kirwan Disposable Battery-powered Cautery, Model 41-61XX series DelcathSystems6324 (BP) - Delcath Dual Hemofiltration Cartridge Tyber6592 (WH,CH1) - Anatomical Plating System Premia (CH1) - ProMIS Extension Rod Kirwan2512 (CH1,NR) - Disposable Endoscopic Cord, Disposable Monopolar Cord Kirwan2512 (CH1,NR) - Monoplar Endoscopic Cord Paragon6351 (NR) - Weck EFX Shield Fascial Closure System Lifenet2559 (WH,CH1*) - I/C Graft Chamber Anodyne3068 (LN, LS) - PEYMAN BVI1689 (EP1) - Soft Tip Cannula BVI1689 (EP1) - LASIK Irrigating Cannula BVI1689 (EP1) - Flexible Tip Cannula BVI1689 (EP1) - Visitec Nucleus Hydrodissector BVI1689 (EP1) - Micro J Shape Cannula BVI1689 (EP1) - Irrigating Cystotome BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft] BVI1689 (EP1) - Viscoflow Cannula BVI1689 (EP1) - Cortical Cleaving Hydrodissector BVI1689 (EP1) - Infusion Cannulas BVI1689 (EP1) - Lacrimal Cannula SonomedEscalon8890 (MN) - Viscous Fluid Cannula Premia (CH1) - TOPS System BioWave4291 (CH1,WH) - Percutaneous Electrodes BVI1689 (EP1) - Atomic Edge Knife BVI1689 (EP1,CH1) - Beaver Micro-Sharp® Blade BVI1689 (EP1) - Beaver Xstar Knives BVI1689 (EP1) - Beaver Micro-Unitome Knife BVI1689 (EP1) - Beaver Sideport MVR Knife BVI1689 (EP1) - Beaver Optimum Knife BVI1689 (EP1, CH1)- Beaver Micro-Sharp® Blade BVI1689 (EP1) - Beaver Swivel Fixation Ring 13mm BVI1689 (EP1) - Beaver Xstar Safety Slit Knife BVI1689 (EP1) - CustomEyes Biomeric6631 (LN) - TrabEx BVI1689 (EP1) - Beaver Xstar Slit Knife Tyber6592 (WH,CH1) - Tyber Medical ACIF; Tyber Medical ALIF; Tyber Medical DLIF; Tyber Medical OLIF; Tyber Medical PLIF; Tyber6592 (WH,CH1) - Tyber Medical TLIF WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 100 Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 10 Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 10M Open System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6 Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 2cm2/Well, 6-Well Cell Culture Plate WilsonWolf3589 (LS,LN*) - G-Rex® 10M-CS Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 24 Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 100M-CS Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6M - 5cm2/Well, 6-Well Cell Culture Plate WilsonWolf3589 (LS,LN*) - G-Rex® 5M Open System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 100M Cell Culture Product WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS Cell Culture Product CorningME1979 (CH1) - Corning Polystyrene Microcarrier beads, Corning Synthemax Microcarrier beads WilsonWolf3589 (LS,LN*) - G-Rex® 500M-TF Tissue Fragment, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 500M, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 6M Well Plate WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Sterile Fluid Path WilsonWolf3589 (LS,LN*) - G-Rex® 500M-CS, Closed System, Research Use Only WilsonWolf3589 (LS,LN*) - G-Rex® 50M-TF Research Use Only BVI1689 (EP1,CH1) - Collagen Temporary Implants 0.3mm x 2mm BVI1689 (EP1,CH1) - Collagen Temporary Implants 0.2mm x 2mm BVI1689 (EP1) - Collagen Implants Variety Pack BVI1689 (EP1) - Collagen Temporary Implants 0.4mm x 2mm Kirwan2512 (CH1,NR) - Needle Electrode, Microdissection Needles CorningME1979 (CH1) - Corning Disposable Spinner Flasks CorningAMG5859 (CH1) - Corning Disposable Spinner Flasks Kirwan2512 (CH1.NR) - Kirwan Disposable Nerve Stimulating Probes, 41-34XX Series Kirwan2512 (CH1.NR) - Monopolar Suction Stimulator BVI1689 (CH1) - Ultracell Spears BVI1689 (CH1) - Ultraclean BVI1689 (CH1) - Visitec Fluid Control Lifenet2559 (WH,CH1*) - FlexiGRAFT GraftLink; FlexiGRAFT GraftLink TS Lifenet2559 (WH,CH1*) - FlexiGRAFT Sutured Lateral Ankle Tendon Construct Lifenet2559 (WH,CH1*) - FlexiGRAFT QuadLink Lifenet2559 (WH,CH1*) - FlexiGRAFT Connect; FlexiGRAFT Connect EXT Lifenet2559 (WH,CH1*) - Dual Link WhiteBurr3283 (WP, CH1) - Jazz Polisher Premia (CH1) - VersaLink Fixation System CookVandergrift (CH1,WH*) - Flexipet® Manipulation Pipette CookVandergrift (CH1,WH*) - Flexipet® Denuding Pipette Lifenet2559 (CH1,WH,LSRTC) - PliaFX Flo Kirwan2512 (CH1, NR) - Bipolar Suction Coagulator Kirwan2512 (CH1,NR) - Disposable Bipolar Coagulating Forceps Kirwan2512 (CH1,NR) - Disposable Bipolar Forceps Kirwan2512 (CH1,NR) - Disposable Bipolar Irrigating Forceps Medcomp5812 (WH,CH1) - Duralock Depuy (NR,CH1) - ATTUNE All Polyethylene Tibia Kirwan2512 (CH1.NR) - Wire Pass Drills, Cranio Blades ParkerLabs2952 (CH1, WH) - Aquasonic® 100 Sterile Ultrasound Transmission Gel Lifenet2559 (CH1, LN, WH*) - Arthrex AlloSync PushLock Suture Anchor Tyber6592 (WH,CH1) - Wedge System Depuy (NR,CH1) - SIGMA® High Performance Partial Knee System J&J2480 (CH1) - Band-Aid CorningME1979 (CH1) - Corning Spinner Flasks and accessories Kirwan2512 (CH1.NR) - Disposable Irrigation Bipolar Cord Assembly Kirwan2512 (CH1.NR) - Disposable Bipolar Irrigating Cord Tyber6592 (WH,CH1) - Tyber Medical PT Interbody Spacer System Kirwan2512 (CH1,NR)- Disposable Bipolar Electrode Kirwan2512 (CH1,NR)- Disposable Bipolar Pencil Coagulator Kirwan2512 (CH1,NR) - Disposable Bipolar Probe BVI1689 (EP1, CH1) - Micro Flow Pre-Loaded Punctal Occluder Hologic (CH1,NR) - Securmark Biopsy Site Markers Merit1383 (TM) - Finale Radial Compression System DVL-Op6436 (TM) - BRCDXL-05 Breast Reduction Compression Device XL DVL-Op6436 (TM) - BRCD-05 Breast Reduction Compression Device Merit1383 (TM) - RADstat Radial Artery Compression Device PrecisionMedical (NR) - T-RING BVI1689 (CH1) - Weck-Cel Sponge Points and Strips BVI1689 (CH1) - Weck-Cel Sponge Points BVI1689 (CH1) - Weck-Cel Cellulose Eye Spear Tyber6592 (WH,CH1) - Staple System Medline (GR,LN) - Aplicare / Medline WhiteBurr3283 (WH,CH1) - SS White Carbide Burs CorningME1979 (CH1) - Custom Transwell Permeable Supports BVI1689 (EP1, CH1) - Plus Pre-Loaded Punctal Occluder Tyber6592 (WH,CH1) - INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL EndoTheia11104 (SP,CH1*) - FlexStone Basket CarpusMed (SP) - NAR Compressed Gauze Hydrofera2363 (NR,WH) - Instrument Wipe ZMedica3625 (NR,WH) - Phokus Nonwoven Bandage CarpusMed (SP) - NAR S-Rolled Gauze Merit1383 (TM) - Worley Slitter Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Contamination Sleeve Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX Tyber6592 (WH,CH1) - Tyber Medical 8 HCS; Tyber Medical 9 HCS Tyber6592 (WH,CH1) - Tyber Medical 5.5 HCS; Tyber Medical 6 HCS; Tyber Medical 6.5 HCS; Tyber Medical 7 HCS; Tyber6592 (WH,CH1) - Tyber Medical 1.5 HCS; Tyber Medical 2 HCS; Tyber Medical 2.5 HCS; Tyber Medical 3 HCS Tyber6592 (WH, CH1) - Tyber Medical 3.5 HCS; Tyber Medical 4 HCS; Tyber Medical 4.5 HCS; Tyber Medical 5 HCS Kirwan2512 (CH1,NR) - Monopolar Suction Coagulator Lifenet2559 (WH,CH1*) - Optium DBM Gel and Putty

    Establishment Types

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