BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Isomedix Operations, Inc.

    Reg #: 2183744 · FEI: 2183744 · Expires 2026
    View on FDA
    Products
    280
    Proprietary Names
    386
    Establishment Types
    2
    Classifications
    280

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2183744
    FEI Number
    2183744
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    380 90TH AVE NW
    City
    Minneapolis
    State
    MN
    ZIP
    55433
    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Introducer, Catheter DYB
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Kit, Surgical Instrument, Disposable KDD
    Syringe, Piston FMF
    Wire, Guide, Catheter DQX
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Prosthesis, Toe, Hemi-, Phalangeal KWD
    Device, Specimen Collection LIO
    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia QXB
    Catheter, Percutaneous DQY
    Thoracolumbosacral Pedicle Screw System NKB
    Electrocautery, Gynecologic (And Accessories) HGI
    Hysteroscope (And Accessories) HIH
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Stent, Ureteral FAD
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Stylet, Tracheal Tube BSR
    Wrench HXC
    Catheter, Nephrostomy LJE
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief NHI
    Biopsy Needle FCG
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Catheter, Peripheral, Atherectomy MCW
    Needle, Aspiration And Injection, Disposable GAA
    Stimulator, Carotid Sinus Nerve DSR
    Light Source, Endoscope, Xenon Arc GCT
    Dilator, Esophageal, Ent KCF
    Catheter And Tip, Suction JOL
    Temporary Carotid Catheter For Embolic Capture NTE
    Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use NQJ
    Catheter, Hemodialysis, Implanted MSD
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Lithotriptor, Ultrasonic FEO
    Prosthesis, Toe, Constrained, Polymer KWH
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Catheter, Recording, Electrode, Reprocessed NLH
    Neurological Stereotaxic Instrument HAW
    Snare, Surgical GAE
    Accelerator, Linear, Medical IYE
    Lithotriptor, Electro-Hydraulic FFK
    Bronchoscope (Flexible Or Rigid) EOQ
    Cover, Barrier, Protective MMP
    System, X-Ray, Tomography, Computed JAK
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Stent, Iliac NIO
    Aid, Surgical, Viscoelastic LZP
    Powered Laser Surgical Instrument GEX
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Manual, Surgical, General Use MDM
    Electrode, Cortical GYC
    Culture Media, Non-Propagating Transport JSM
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Insufflator, Laparoscopic HIF
    Bronchoscope Accessory KTI
    Device, Vascular, For Promoting Embolization KRD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Eustachian Tube Balloon Dilation Device PNZ
    Instrument, Ent Manual Surgical LRC
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Stylet For Catheter, Gastro-Urology EZB
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Accessories, Catheter, G-U KNY
    Spinous Process Plate PEK
    Light, Surgical, Fiberoptic FST
    Syringe, Irrigating (Non Dental) KYZ
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Device, Anastomotic, Microvascular MVR
    Flowmeter, Blood, Cardiovascular DPW
    Tube, Aspirating, Flexible, Connecting BYY
    Computer, Diagnostic, Programmable DQK
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Septostomy DXF
    Tape, Measuring, Rulers And Calipers FTY
    Securement Wound Dressing For Reduction Of Infection SEL
    Catheter, Steerable DRA
    Catheter, Intravascular Occluding, Temporary MJN
    Gown, Surgical FYA
    Drape, Surgical, Antimicrobial KKX
    Catheter, Percutaneous, Cutting/Scoring PNO
    Lock, Wire, And Ligature, Intraoral DYX
    Catheter, Thrombus Retriever NRY
    Tube, Smoke Removal, Endoscopic FCZ
    Instruments, Surgical, Cardiovascular DWS
    Instrument, Ultrasonic Surgical LFL
    Tubes, Gastrointestinal (And Accessories) KNT
    Catheter, Urological KOD
    Plug, Punctum LZU
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Coil, Magnetic Resonance, Specialty MOS
    Catheter, Percutaneous, Neurovasculature QJP
    Tong, Skull For Traction HAX
    Arthroscope HRX
    Cannula, Manipulator/Injector, Uterine LKF
    Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse PWK
    Electrode, Depth GZL
    Artificial Chordae Tendinae Delivery System PCX
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Cannula, Sinus KAM
    Retractor GAD
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK
    Catheter For Crossing Total Occlusions PDU
    Reprocessed Intravascular Ultrasound Catheter OWQ
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Clamp, Vascular DXC
    Dressing, Wound, Drug FRO
    Device, Biopsy, Endomyocardial DWZ
    Drug-Coated Peripheral Transluminal Angioplasty Catheter PRC
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Button, Nasal Septal LFB
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Transcatheter Septal Occluder MLV
    Splint, Intranasal Septal LYA
    Generator, Lesion, Radiofrequency GXD
    Probe, Radiofrequency Lesion GXI
    Catheter, Ureteral, Gastro-Urology EYB
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Device, Hemostasis, Vascular MGB
    Gastroscope And Accessories, Flexible/Rigid FDS
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Lipoaspirate Washing System For Aesthetic Body Contouring QKL
    Implanted Subcutaneous Securement Catheter OKC
    Device, Intravascular Catheter Securement KMK
    Bottle, Collection, Vacuum KDQ
    Tube, Tympanostomy ETD
    Catheter, Coronary, Atherectomy MCX
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Reprocessed Bronchoscope QNW
    Single-Use Reprocessed Ultrasonic Surgical Instruments NLQ
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Bag, Bile Collecting EXF
    Aspiration Thrombectomy Catheter QEZ
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON
    Stent, Iliac Vein QAN
    System, Appendage Closure, Left Atrial NGV
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Fixation, Non-Absorbable Or Absorbable, For Pelvic Use PBQ
    Marker, Radiographic, Implantable NEU
    Warmer, Thermal, Infusion Fluid LGZ
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Endoscope, Neurological GWG
    Catheter, Continuous Flush KRA
    Resectoscope FJL
    Electrode, Electrosurgical, Active, Urological FAS
    Resectoscope, Working Element FDC
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Device, Impotence, Mechanical/Hydraulic FHW
    Suture, Recombinant Technology NWJ
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Bandage, Liquid KMF
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Coronary Drug-Eluting Stent NIQ
    Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access PQK
    Dilator, Esophageal KNQ
    Tube, Tracheal (W/Wo Connector) BTR
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Antistick MEG
    Dislodger, Stone, Flexible FGO
    Accessories, Catheter KGZ
    Catheter, Balloon Type GBA
    Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection NFA
    Permanent Pacemaker Electrode DTB
    Stent, Superficial Femoral Artery NIP
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Guide, Surgical, Instrument FZX
    Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse PWI
    Tubing, Replacement, Phacofragmentation Unit MSR
    Catheter, Intracardiac Mapping, High-Density Array MTD
    Sensor, Glucose, Implanted, Non-Adjunctive Use QHJ
    Continuous Glucose Monitor, Implanted, Adjunctive Use QCD
    Mesh, Surgical FTM
    Tape And Bandage, Adhesive KGX
    Stimulator, Hypoglossal Nerve, Implanted, Apnea MNQ
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Pick, Microsurgical Ear JYT
    Cannula, Surgical, General & Plastic Surgery GEA
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Instrument, Surgical, Disposable KDC
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Probe HXB
    Catheter, Embolectomy DXE
    Medical Device Data System OUG
    Catheter, Multiple Lumen GBP
    Endoscopic Cytology Brush FDX
    Cable, Electrode IKD
    Pacemaker Lead Adaptor DTD
    System, Facet Screw Spinal Device MRW
    Stent, Carotid NIM
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Cover, Burr Hole GXR
    Applicator, Absorbent Tipped, Sterile KXG
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC
    System, Thermal Regulating DWJ
    Dilator, Urethral KOE
    Heart-Valve, Non-Allograft Tissue LWR
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Stent, Urethral, Prostatic, Semi-Permanent NZC
    Occluder, Patent Ductus, Arteriosus MAE
    Balloon, Epistaxis EMX
    Tissue Expander And Accessories LCJ
    Stimulator, Nerve ETN
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Device, Monitoring, Intracranial Pressure GWM
    Electrode, Electrosurgical JOS
    Stylet, Ureteral EYA
    Stimulator, Thalamic, Epilepsy, Implanted MBX
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Pad, Kelly FNW
    Transducer, Pressure, Catheter Tip DXO
    Computer, Blood-Pressure DSK
    Device, Percutaneous Retrieval MMX
    Table, Operating-Room, Ac-Powered FQO
    Insufflator, Endoscopic Vessel Harvesting OSV
    Prosthesis, Penile FAE
    Pulse-Generator, Pacemaker, External DTE
    Device, Irrigation, Ocular Surgery KYG
    Hemostatic Wound Dressing With Thrombin Or Other Biologics QSX
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Pump, Infusion, Ophthalmic MRH
    Stent, Vaginal KXP
    System, Perfusion, Kidney KDN
    Instrument, Surgical, Non-Powered HAO
    Orthopedic Manual Surgical Instrument LXH
    Sponge, Ophthalmic HOZ
    Catheter, Balloon, Urethral, Drug-Coated QRH
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Dilator, Vessel, Surgical DWP
    Cannula, Ophthalmic HMX
    Needle, Catheter GCB
    Ear Wick KCN
    Eyelid Thermal Pulsation System ORZ
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Implant, Hearing, Active, Middle Ear, Partially Implanted MPV
    Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb SAZ
    Lens, Condensing, Diagnostic HJL
    Central Venous Catheter Dressing Change Kit PEZ
    Tracheal Suction Set OFS
    Neurosurgical Laser With Mr Thermography ONO
    Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Implanted Subcortical Electrical Stimulator (Motor Disorders) MRU
    Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) OLM
    Catheter, Intracardiac Mapping, High-Density, Reprocessed NLG
    Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate SBA
    Endoscopic Irrigation/Suction System OCX
    Prism, Gonioscopic HKS
    Implant, Hearing, Active, Middle Ear, Totally Implanted OAF
    Motor, Surgical Instrument, Ac-Powered GEY
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy MEQ
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    System, Balloon, Intra-Aortic And Control DSP

    Proprietary Names

    Olympus2295 (MN) - PKS Cutting Forceps Olympus2295 (MN) - Cutting Forceps Medtronic2686 (MN) - RapidCross RX PTA Catheter StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE BVI1689 (EP1) - CustomEyes Zimmer (LN,LS) - Toggleloc Zimmer (LN,LS) - Maxfire Acuderm1463 (WH,LS) -Acu-Punch Kit Medtronic2686 (MN) - Chocolate™ PTA Catheter Olympus2295 (MN) - POWERSEAL 2 ThermoFisher3721 (MN) - BactiSwab NPG (Mod Stuarts) PK/100 Spineology5627 (MN) - Threshold V2 Pedicular Fixation System Spineology5627 (MN) - Palisade Pedicular Fixation System Spineology5627 (MN) - Threshold Pedicular Fixation System Spineology5627 (MN) - Fortress Pedicular Fixation System Spineology5627 (MN) - ConneX Connectors Olympus2295 (MN) - Disposable Bipolar Cord Olympus2295 (MN) - Double Pigtail Synovis6299 (MN) - GEM FLOW NOW Doppler BloodFlow Monitoring Device VerathonMedical5877 (WT) - GlideRite Single-Use Stylet - Small VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System Surmodics4211 (MN) - PounceTM Sheath Ursel11054 (MN) - Nephro-Stent Lutonix5247 (MN) - Lutonix 014 Drug Coated Balloon PTA Catheter Lutonix5247 (MN) - Lutonix 014 RX Drug Coated Balloon PTA Catheter Lutonix5247 (MN) - Bard LTX 014 Drug Coated Balloon PTA Catheter Nextern7783 (MN) - SPRINT Peripheral Nerve Stimulation (PNS) System Olympus2295 (MN) - NA-U401SX-4021 Olympus2295 (MN) - NA-U401SX-4022 Jetstream XC &SC Systems 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 Quadrant9161 (MN) - Infinity Balloon Dilation Catheter SilkRoad5492 (MN) - Temporary Carotid Catheter for Embolic Capture Nuwellis6365 (MN) - DUAL LUMEN EXTENDED LENGTH CATHETER Olympus2295 (MN) - ShockPulse Olympus2295 (MN) - Lubri-Flex Stents Surmodics4211 (MN) - PounceTM LP Thrombectomy System Anodyne3068 (LN, LS) - MULTIPLE SNARES Civco14101 (MN) - Fiducial Markers VascularSolutions3517 (MN) - Venture catheter Olympus2295 (MN) - Electrohydraulic Lithotripsy Probes Aspen1609 (EP1,MN) - System Drapes Medtronic2686 (MN) - Visi-Pro Ballon-expandable Peripheral Stent System Medtronic2686 (MN) - SpiderFX Embolic Protection Device Freudenberg4179 (MN) - Empower / FlexSeal BeInnovative11045 (LN) - Rotolock Cord Management System Hydrofera (NR, WH) - Instrument Wipe SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R Etex2142 (NR) - Precision Cannula 150 mm PhoenixMed2991 (SP) - Various Instruments Acuderm1463 (WH,LS) - Acu-Dispo-Ce PhoenixMed2991 (SP) - Instrument, manual, surgical, general use Abyrx4508 (WH) - Abyrx Putty Applicator Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Protech3048 (TM) - PHANTOM ML LIGHT CABLE Design2052 (NR) - CTS Relief Kit ThermoFisher3721 (MN) - BactiSwab (Mod Stuarts) PK/100 VascularSolutions3517 (MN) - PiggyBack Wire Converter Lexion2551 (MN) - Insuflow AccessPoint5418 (MN) - MAGiC Sweep EP Mapping Catheter Spineology5627 (MN) - Rampart O Lumbar Interbody Fusion System Olympus2295 (MN) - Double J Stent Olympus2295 (MN) - Endoscopic cord Spineology5627 (MN) - VIA Spinous Process Fixation System Spineology5627 (LN) - Rampart One Lumbar Interbody Fusion System Synovis6299 (MN) - GEM FLOW COUPLER VascularSolutions3517 (MN) - TrapLiner catheter VascularSolutions3517 (MN) - GrebSet micro-introducer kit Puritan5503 (NR) - Puritan, DM Stick Sterile Foam Tipped Measuring Device Olympus2295 (MN) - PKS Seal Open Forceps Olympus2295 (MN) - Open Forceps Kardium5673 (MN) - Globe® Introducer Olympus2295 (MN) - HALO ThermoFisher3721 (MN) - ACT II Dual Transport PK/10 ThermoFisher3721 (MN) - ACT II Transport PK/10 Medtronic2686 (MN) - Wholey Guidewire System Aspen1609 (EP1,MN) - Probe Cover MegaDyne1382 (SN) - Megadyne Laparoscopic Tubing Merit1383 (TM) - Worley Slitter Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Contamination Sleeve Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX QXMedical6079 (MN) - Q50 PLUS Stent Graft Balloon Catheter Olympus2295 (MN) - Thunderbeat II Teleflex (EP2) - Lake Region Guide Wire TerumoMed3380 (NR) - Mandrel Guidewire Assembly BD9423 (MN) - Personal Catheter BD9423 (MN) - Magic3 BD9423 (NT) - HydroSil BD9423 (NT) - Hydro Soft Medtronic2686 (MN) - AqWire Hydrophilic Guidewire Surmodics4211 (MN) - PounceTM XL Thrombectomy System Olympus2295 (MN) - Silicone Single J AngioJet Ultra AVX Thrombectomy Set Olympus2295 (MN) - Power laser surgical Instrument Olympus2295 (MN) - Powered laser surgical system- Soltive Olympus2295 (MN) - Uro Guide Olympus2295 (MN) - POWERSEAL Neochord8848 (MN) - DS1000 Olympus2295 (MN) - BIPOLAR COAGULATING FORCEPS OmegaSurgical (LSRTC) - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Zimmer (LN) - blade, saw, general and plastic surgery, surgical StrykerPR3324 (GR, LS, VG) - PKG ,ENT IRR.AGG.SHAVER BLADE StrykerPR3324 (GR, LS, VG) - SJ Cutter Mnscs StrykerPR3324 (GR, LS, VG) - Cutter Meniscus StrykerPR3324 (GR) - 4 mm ENT MicroDebrider AGGRESSIVE SERRATED StrykerPR3324 (GR, LS, VG) - Cutter Full Radius StrykerPR3324 (GR, LS, VG) - Bur TMJ 2mm StrykerPR3324 (GR, LS, VG) - Bur TMJ 3mm StrykerPR3324 (GR, LS, VG) - SJ Cutter StrykerPR3324 (GR, LS) - 4mm Aggressive Serrated StrykerPR3324 (GR, LS, VG) - SHARPEDGE SHAVER BLADE 4MM StrykerPR3324 (VG) - Full Radius Cutter, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Hooded Abrasion Bur, Arthroscopic Shaver Blade StrykerPR3324 (VG) - Aggressive Cutter, Arthroscopic Shaver Blade OrchidUnique5936 (LN) - Blade, Saw, General & Plastic Surgery, Surgical - Signature Series UltraLite Aspen1609 (EP1,MN) - Probe Cover, Endocavity Olympus2295 (MN) - Plasma J Hook Olympus2295 (MN) - J PlasmaKnife Spineology5627 (MN) - E Blades/Rakes Spineology5627 (MN) - SOAR Portal Tubes Protech3048 (TM) - Metaphyseal Kit, 5 Pack Spineology5627 (MN) - Retractor Protech3048 (TM) - Diaphyseal Kit, Single Spineology5627 (MN) - Duo Disposable Instruments Protech3048 (TM) - Universal Pin in Place Guide Protech3048 (TM) - Diaphyseal Kit, 5 Pack Volks5717 (MN) - Disposable Direct Image Flat SSV Box of 10 Volks5717 (MN) - Single Use Indirect Wide Field Box of 10 Volks5717 (MN) - Disposable Direct Image WideField Box of 10 Volks5717 (MN) - Disposable Direct Image BiConcave Box of 10 Volks5717 (MN) - Disposable Direct Image 1.5x Mag Box of 10 Volks5717 (MN) - Disposable Direct Image Flat Box of 10 Volks5717 (MN) - Disposable Direct Image 30 Prism Box of 10 Synovis6299 (MN) - Flo-Thru Intraluminal Shunt Olympus2295 (MN) - ASV1012 Lutonix5247 (MN) - Lutonix 035 Drug Coated Balloon PTA Catheter Lutonix5247 (MN) - Lutonix 018 Drug Coated Balloon PTA Catheter Aspen1609 (EP1,MN) - Neddle Guides, General Purpose Aspen1609 (EP1,MN) - Transrectal Needle Guide Olympus2295 (MN) - 2-3/4 Needle Electrode Covidien4236 (MN) - HawkOne Directional Atherectomy System 6F VascularSolutions3517 (MN) - Spectre guidewire Olympus2295 (MN) - Dual Lumen Catheter Nuwellis6365 (MN) - AquaFlexFlow VascularSolutions3517 (MN) - D-Stat Flowable Olympus2295 (MN) - Plasma Cut Olympus2295 (MN) - Gyrus Plasma V Interrad4661 (MN) - SecurAcath Atrium1623 (NR) - Chest Drain Accessories Ursel11054 (MN) - Thora-Vent Thoracic Vent PFMMedical6614 (TM) - Asept; Jet-Vac Olympus2295 (MN) - AUR-735 Olympus2295 (MN) - BIOPSY PORT SEALS StrykerSustainability (MN) - Reprocessed HARMONIC 700 Shears Ursel11054 (MN) - Optimus Merit1383 (TM) - Merit Drainage Depot VascularSolutions3517 (MN) - Pronto LP extraction catheter Lexion2551 (MN) - VesselGuardian Olympus2295 (MN) - McCarthy Electrode Olympus2295 (MN) - Fulgurating Electrode Olympus2295 (MN) - Roller Electrode Olympus2295 (MN) - Elite 2 System Olympus2295 (MN) - Stabilized Cutting Loops Medtronic2686 (MN) - Abre Venous Self-expanding Stent System Olympus2295 (MN) - CyberWand Medtronic2686 (MN) - NanoCross Elite™ PTA Catheter Medtronic2686 (MN) - Trailblazer Angled Support Catheter Vesper8286 (MN) - Duo Venous Stent System ItekMed5707 (MN) - EnVisio Navigation System Navigator and Calibration Disk Olympus2295 (MN) - Celeris Synovis6299 (MN) - Flo-Rester Disposable Internal Vessel Occludr Ursel11054 (MN) - GP General Purpose Drainage Catheter Ursel11054 (MN) - Aspiration and Flush Assembly Ursel11054 (MN) - Nephro-Cath Nephrostomy Drainage Catheter Ursel11054 (MN) - Ulti-Flo General Purpose Drainage Catheter Medtronic2686 (MN) - The Big Easy Rotating Y-Connector with Adjustable Valves Medtronic2686 (MN) - The Sequel Double Rotating Y-Connectors with Adjustable Valves Olympus2295 (MN) - Cyberwand Ursel11054 (MN) - TRU-CLOSE Suction Drainage System Elixir4098 (MN) - DESyne X2 Novolimus Eluting Coronary Stent System BD9423 (MN) - WavelinQ EndoAVF System Quadrant9161 (MN) - Tenax Olympus2295 (MN) - SUR-CATCH BASKET VascularSolutions3517 (MN) - Micro Elite snare PFMMedical6614 (TM) - Jet-Vac Drainage Line (Ref M7099) PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref M7004) PFMMedical6614 (TM) - Jet-Vac Large Bore Drainage Line Set (Ref M7098) PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref M7005) PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097) PFMMedical6614 (TM) - ASEPT Power Flush Adaptor Ursel11054 (MN) - Posi-Stick Introducer Set Prava (LSRTC) - UGARing Merit1383 (TM) - Prelude SNAP 165 Valved Splittable Sheath Introducer Spineology5627 (MN) - Verify ThermoFisher3721 (MN) - BactiSwab II (Mod Stuarts) PK/100 Olympus2295 (MN) - Bicoag Hemostatis Probe Olympus2295 (MN) - Vaportrode Medtronic2686 (MN) - Protege EverFlex Self-expanding Peripheral Stent System Medtronic2686 (MN) - Babywire™ Double Ended Nitinol Guidewire Zimmer (LN) - Carpal Tunnel Release Instruments Zimmer (LN) - ACL GUIDE WIRE DISP KIT Zimmer (LN) - K-WIRE 0.45 (1.1MM) X 9'' PARTIALLY THREADED Atricure2121 (GR) - Atricure - Gillinov-Cosgrove Selection Guide OmegaSurgical (LSRTC) - Guide, surgical, instrument SonomedEscalon8890 (MN) - Universal Viscous Fluid Control Pack SonomedEscalon8890 (MN) - Viscous Fluid System Pack Olympus2295 (MN) - Micro Forceps Olympus2295 (MN) - Macro Forceps Olympus2295 (MN) - MOLly Forceps Synovis6299 (MN) - Peri-Strips Dry with Veritas 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 EAR PICK VascularSolutions3517 (MN) - GuideLiner V3 catheter Olympus2295 (MN) - TB-0535FCS Zimmer Biomet (LS) - HydroDam Cannula System Zimmer (LS) - HydroDam Cannula System Medtronic2686 (MN) - NITREX Guidewire VascularSolutions3517 (MN) - VSI StraightSet micro-introducer Olympus2295 (MN) - SlimLine Medtronic2686 (MN) - Amplatz Goose Neck Snare Kit Volks5717 (MN) - Disposable Iridotomy Box of 10 Volks5717 (MN) - Disposable Capsulotomy Box of 10 VascularSolutions3517 (MN) - Vari-Lase laser fiber and procedure kits SilkRoad5492 (MN) - ENROUTE Transcarotid Neuroprotection System Gyrus2295 (MN) - PeriView FLEX Olympus2295 (MN) - BC-V600P-3010 Medtronic2686 (MN) - Trailblazer Support Catheter AccessPoint5418 (MN) - Map-iT VascularSolutions3517 (MN) - Turnpike catheters VascularSolutions3517 (MN) - Bandit guidewire VascularSolutions3517 (MN) - VSI Guidewire Spineology5627 (MN) - Capture Facet Spineology5627 (MN) - Spineology Facet Screw System Smith&Nephew3754 (NR) - (6) Passing Pins, Drill Tip, 2.7mm x 381mm Smith&Nephew3754 (NR) - 4.5 Incisor S&N3754 (NR) - Drill, 1.6mm and Guide, Dynomite™ 2 Smith&Nephew3754 (NR) - Drill, 2.6mm and Guide, Raptormite™ 3 S&N3754 (NR) - Drill, 3.2mm and Guide, Raptormite™ 3.7 Smith&Nephew3754 (NR) - Drill, 1.8mm and Guide, Spyromite™ / Minitac™2 Wolfmed8101 (MN) - DIAMOND BURR 3MM WL 350MM ROUND Olympus2295 (MN) - PKS Plasmaspatula Medtronic2686 (MN) - IntraStent Mega/Max LD Stent Biliary Olympus2295 (MN) - Sof-Curl MML1375 (SN) - MML Specimen Collection Swab Ensera7760 (GR,SP) - Sterile Flocked Swab Ensera7760 (GR,SP) - SteriPack Sterile Polyester Spun Swab Ensera7760 (LN,SP) - Sterile 3" Foam Swab with yellow handle v2 Puritan5503 (NR) - CaligSwab; HydraFlock; PurFlock Ultra; Puritan, Pur-Wraps; PurSwab SteriPackUSA7760 (SP) - Sterile Foam Swab with yellow handle Puritan5503 (NR) - Sterile Foam Tipped Applicator Puritan5503 (NR) - Hospital, Sterile Cotton Tipped Applicators Robling1585 (SP) - ClearTip Swab Ultra Thin Birchwood1772 (MN) - Scopettes JR Puritan5503 (NR) - Sterile Cotton Tipped Applicators Puritan5503 (NR) - Puritan, Sterile Polyester Tipped Applicators EdwardsLife6723 (TM) - MITRIS RESILIA Mitral Valve EdwardsLife6723 (MN,TM) - KONECT RESILIA Aortic Valved Conduit Olympus2295 (MN) - PK NEEDLE VascularSolutions3517 (MN) - Minnie Support Catheter ProMed6663 (MN) - Spanner Prostatic Stent Olympus2295 (MN) - Pleatman Sac and accessories Olympus2295 (MN) - Quadra Coil EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Small EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Large EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Medium EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer (TSP/I) System - Large EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer (TSP/I) System - Medium EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - X-Small EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer (TSP/I) System - Small Olympus2295 (MN) - PKS Dissectors Olympus2295 (MN) - Dissector Forceps L&Z7835 (MN) - CATHTONG I PICC Catheter BAK/C, BAK/C Vista Spine5627 (MN) - Palisade Pedicular Fixation System Olympus2295 (MN) - PK Needle Olympus2295 (MN) - PKS Needle VascularSolutions3517 (MN) - R350 guidewire Olympus2295 (MN) - Electrode Blade Olympus2295 (MN) - Ureteral Catheter Medtronic2686 (MN) - Fortrex HP PTA Balloon Catheter VascularSolutions3517 (MN) - Twin-Pass Torque Aspen1609 (EP1,MN) - Needle Guides, General Purpose Medtronic2686 (MN) - Amplatz Goose Neck Microsnare Kit Quadrant9161 (MN) - aeris VascularSolutions3517 (MN) - Sympro Elite snare VascularSolutions3517 (MN) - Expro Elite snare Medtronic2686 (MN) - Protege RX Self-expanding Carotid and Peripheral Stent System Lexion2551 (MN) - INSUFLOW PORT Medtronic2686 (MN) - EverCross™ PTA Catheter Ursel11054 (MN) - Chole-Cath StrykerSustainability (MN) - Reprocessed HARMONIC 1100 Shears Nextern7783 (MN) - Solo Pace Control Olympus2295 (MN) - PKS Omni Spineology5627 (MN) - Elite Expandable Interbody Fusion System VascularSolutions3517 (MN) - VSI Torque Device Surmodics4211 (MN) - PounceTM Venous Thrombectomy System Spine5627 (MN) - Fortress Pedicular Fixation System ThermoFisher3721 (MN) - BactiSwab (Dry) PK/100 FHC10821 (MN) - Unibody™ Bone Fiducials (7mm) FHC10821 (MN) - Unibody™ Bone Fiducials (13mm) FHC10821 (MN) - Unibody™ Bone Fiducials (10mm) Surmodics4211 (MN) - SublimeTM Microcatheter Olympus2295 (MN) - Uropass Ureteral Access Sheaths SPS9653 (MN) - Uretero 1 Disposable Ureteroscope Medtronic2686 (MN) - Enteer Re-entry Catheter Medtronic2686 (MN) - Enteer Guidewire Medtronic2686 (LN) - Viance Crossing Catheter Lutonix5247 (MN) - Lutonix 014 Drug Coated Balloon PTCA Catheter Synovis6299 (MN) - Vascular Probe/ Vascular Probe Extra Supple (ES) 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 Auris9616 (TM) - Monarch Platform PFMMedical6614 (TM) - Scripps 5F x 10cm Jet-Vac Procedure Trays (Ref: M7854SC) PFMMedical6614 (TM) - 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613211) PFMMedical6614 (TM) - Palomar 5F x 7cm Jet-Vac Procedure Trays (Ref M7853P) Ranfac3098 (NR) - GIU-30, 31G-END, 30G-END, GIU-31 PFMMedical6614 (TM) - 5F x 15cm Jet-Vac Centesis Catheter (Ref M7515) PFMMedical6614 (TM) - 4F x 7cm Jet-Vac Centesis Catheter (Ref M7511) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554NM) PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Centesis Catheter (Ref M7512) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554) Merit1383 (TM) - Mak-NV PFMMedical6614 (TM) - Palomar 5F x 10cm Jet-Vac Procedure Trays (Ref M7854P) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Centesis Catheter (Ref M7514) PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Safety Procedure Tray (Ref M7553) PFMMedical6614 (TM) - 5F x 15cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613214) PFMMedical6614 (TM) - Eisenhower 5F x 7cm Jet-Vac Procedure Tray (Ref M7853EI) PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Centesis Catheter (Ref M7513) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref M7854) PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Safety Procedure Tray (Ref M7552) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref 850007) PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Procedure Tray (Ref M7853) PFMMedical6614 (TM) - Eisenhower 5F x 10cm Jet-Vac Procedure Tray (Ref M7854EI) PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Procedure Tray (Ref M7852) PFMMedical6614 (TM) - 4F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613210) Ranfac3098 (NR) - Sialography Unit Endport PFMMedical6614 (TM) - 5F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613212) Merit1383(TM) - Introducer Needle with Trocar Stylet, PFMMedical6614 (TM) - 5F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613213) Medivators2752 (EP1) - CLEANASCOPE Linerset Olympus2295 (MN) - Cleaning Accessories Volks5717 (MN) - Single Use 20D Box of 10 Volks5717 (MN) - Single Use 28D Box of 10 Synovis6299 (MN) - PSD Gel with Tip VascularSolutions3517 (MN) - Pronto V4 extraction Catheter VascularSolutions3517 (MN) - Raider guidewire Surmodics4211 (MN) - PounceTM Thrombectomy System Nuwellis6365 (MN) - Aquadex FlexFlow Blood Circuit Spineology5627 (MN) - Rampart O Aspen1609 (MN,EP1) - Probe Cover Olympus2295 (MN) - IrriFlow Olympus2295 (MN) - Extend Blade Eelectrode Volks5717 (MN) - Disposable 4-Mirror box of 10 Volks5717 (MN) - Disposable SLT Box of 10 Volks5717 (MN) - Disposable 3-Mirror Box of 10 QXMedical6079 (MN) - Boosting Catheter Olympus2295 (MN) - Aspiration needle Olympus2295 (MN) - PK-CF0533 Kardium5673 (MN) - Globe® Catheter Clarus1917 (MN) - LASE (Cervical) Olympus2295 (MN) - POWERSEAL OPEN EXTENDED JAW

    Establishment Types

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