BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ISOMEDIX OPERATIONS INC.

    Reg #: 1047843 · FEI: 1047843 · Expires 2026
    View on FDA
    Products
    223
    Proprietary Names
    394
    Establishment Types
    2
    Classifications
    222

    Registration Details

    Registration Name
    ISOMEDIX OPERATIONS INC.
    Registration Number
    1047843
    FEI Number
    1047843
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2072 Southport Rd
    City
    SPARTANBURG
    State
    SC
    ZIP
    29306
    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
    Instrument, Ultrasonic Surgical LFL
    Set, Administration, Intravascular FPA
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Cable, Electrode IKD
    Stylet, Tracheal Tube BSR
    Endoscopic Storage Cover OCU
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    LDH
    Orthopedic Stereotaxic Instrument OLO
    Washer, Bolt Nut HTN
    Catheter, Continuous Flush KRA
    Connector, Ureteral Catheter EYK
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Sleeve, Limb, Compressible JOW
    Saline, Vascular Access Flush NGT
    Barrier, Animal Source, Intraoral NPL
    Endoscopic Irrigation/Suction System OCX
    Stimulator, Nerve ETN
    Prosthesis, Chin, Internal FWP
    Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE
    Laser, Ophthalmic HQF
    Unit, Phacofragmentation HQC
    System And Accessories, Isolated Heart, Transport And Preservation MSB
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Container, Specimen, Sterile FMH
    Retractor, Fiberoptic FDG
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Mesh, Surgical, Polymeric FTL
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Needle, Aspiration And Injection, Disposable GAA
    Screw, Fixation, Bone HWC
    Folders And Injectors, Intraocular Lens (Iol) MSS
    Dilator, Urethral KOE
    Dilator, Lachrymal HNW
    Prosthesis, Hip, Femoral, Resurfacing KXA
    Pump, Infusion FRN
    Syringe, Piston FMF
    Device, Intravascular Catheter Securement KMK
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Tubing, Pressure And Accessories BYX
    Instrument, Manual, Surgical, General Use MDM
    Cannula, Trocar, Ophthalmic NGY
    Apparatus, Electrosurgical HAM
    Neurological Stereotaxic Instrument HAW
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Forceps, Biopsy, Non-Electric FCL
    Dislodger, Stone, Flexible FGO
    Stimulator, Hypoglossal Nerve, Implanted, Apnea MNQ
    Syringe, Balloon Inflation MAV
    Syringe, Irrigating (Non Dental) KYZ
    Extractor HWB
    Instrument, Ent Manual Surgical LRC
    Snare, Flexible FDI
    Infusor, Pressure, For I.V. Bags KZD
    Catheter, Steerable DRA
    Plug, Punctum LZU
    Trap, Sterile Specimen BYZ
    Accessories, Pump, Infusion MRZ
    Dressing, Wound, Drug FRO
    Accessories, Cleaning Brushes, For Endoscope MNL
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Staple, Fixation, Bone JDR
    Cerclage, Fixation JDQ
    Transducer, Ultrasonic, Diagnostic ITX
    Colonoscope And Accessories, Flexible/Rigid FDF
    Bit, Drill HTW
    File, Pulp Canal, Endodontic EKS
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Tube, Tracheal (W/Wo Connector) BTR
    Anti Fog Solution And Accessories, Endoscopy OCT
    Laparoscope, General & Plastic Surgery GCJ
    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation OCM
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Tube, Aspirating, Flexible, Connecting BYY
    Accessories, Catheter KGZ
    Trephine, Manual, Ophthalmic HRH
    Needle, Tumor Localization MIJ
    Embolization Agent, Vascular QVG
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    System, Suction, Lipoplasty For Removal QPB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, Image Processing, Radiological LLZ
    Stimulator, Electrical, Evoked Response GWF
    Electromyograph, Diagnostic IKN
    Neurosurgical Nerve Locator PDQ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Hysteroscope (And Accessories) HIH
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Endoscopic Cytology Brush FDX
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Set, I.V. Fluid Transfer LHI
    Snare, Non-Electrical FGX
    Instruments, Surgical, Cardiovascular DWS
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Pump, Infusion, Pca MEA
    Fluid Jet Removal System PZP
    Pump, Air, Non-Manual, For Endoscope FEQ
    Electronic Depth Gauge OOL
    Unit, Cryosurgical, Accessories GEH
    Catheter, Septostomy DXF
    Drape, Surgical, Antimicrobial KKX
    Antimicrobial Drapes PLY
    Instrument, Ligature Passing And Knot Tying HCF
    Applicator, Absorbent Tipped, Sterile KXG
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Cuff, Tracheal Tube, Inflatable BSK
    Lamp, Surgical FTD
    Bronchoscope Accessory KTI
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Bag, Bile Collecting EXF
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator PAG
    Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical FTM
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Catheter, Irrigation GBX
    Cannula, Manipulator/Injector, Uterine LKF
    Lens, Guide, Intraocular KYB
    Prosthesis, Spinous Process Spacer/Plate NQO
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Adaptor, Catheter GCE
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Accessory, Surgical Apparel LYU
    Instrument, Surgical, Non-Powered HAO
    Catheter, Assisted Reproduction MQF
    Clip, Implantable FZP
    Container, I.V. KPE
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Allergen And Vaccine Delivery Needles SCL
    Rod, Colostomy EZP
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Dressing, Wound, Occlusive NAD
    Endoscope Channel Accessory ODC
    Gauze/Sponge, Internal EFQ
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Gauze / Sponge,Nonresorbable For External Use NAB
    Bag, Urine Collecting, Ureterostomy EXG
    Stopcock, I.V. Set FMG
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Light, Surgical, Fiberoptic FST
    Thoracolumbosacral Pedicle Screw System NKB
    Securement Wound Dressing For Reduction Of Infection SEL
    Filler, Bone Void, Calcium Compound MQV
    Component, Traction, Invasive JEC
    Hemostatic Metal Clip For The Gi Tract PKL
    Marker, Skin FZZ
    Bandage, Liquid KMF
    Keratoprosthesis, Permanent Implant HQM
    Bag, Stomal GDS
    Catheter, Percutaneous DQY
    Catheter, Intravascular, Diagnostic DQO
    Catheter, Percutaneous, Neurovasculature QJP
    Flowmeter, Blood, Cardiovascular DPW
    Temporary, Internal Use Hemostatic POD
    Syringe, Balloon Inflation, Exempt PTM
    System, X-Ray, Tomography, Computed JAK
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Infusion Safety Management Software PHC
    Intravascular Radiation Delivery System MOU
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Gastric Irrigation And Aspiration Kit PRT
    Orthopedic Manual Surgical Instrument LXH
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Electrode, Needle GXZ
    Electrode, Cutaneous GXY
    Glue, Surgical, Arteries MUQ
    Tourniquet, Nonpneumatic GAX
    Neurosurgical Paddie HBA
    Monitor, Microbial Growth JTA
    Sheet, Burn FPY
    Iodinated Contrast Media Transfer Tubing Set PQH
    Light, Surgical, Accessories FTA
    Kit, Surgical Instrument, Disposable KDD
    Wound Dressing With Animal-Derived Material(S) KGN
    Sealant, Microbial NZP
    Device, Percutaneous Retrieval MMX
    Table, Operating-Room, Ac-Powered FQO
    Sampler, Endocervical PCF
    Pump, Infusion, Insulin Bolus OPP
    Instrument, Biopsy KNW
    Injector And Syringe, Angiographic DXT
    Tester, Pacemaker Electrode Function DTA
    System, X-Ray, Mammographic IZH
    Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
    Mediastinoscope, Surgical EWY
    Dressing, Compression MHW
    System, Hemodynamic, Implantable MOM
    Central Venous Catheter Dressing Change Kit PEZ
    Cement Obturator LZN
    Drape, Surgical, Exempt PUI
    Media, Corneal Storage LYX
    Tissue Adhesive For The Topical Approximation Of Skin MPN
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Collector, Ostomy EXB
    Monitor, Bed Patient KMI
    Organ Care System (Ocs) Heart System QIK
    Shunt, Central Nervous System And Components JXG
    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation QQK
    Dressing, Wound, Hydrophilic NAC
    Biopsy Needle FCG
    Tape And Bandage, Adhesive KGX
    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation QBA
    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs PHO
    Tray, Surgical, Instrument FSM
    General Surgery Tray LRO
    Cannula, Ophthalmic HMX
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    Carefusion (SP) - Electrodes VMuller7956 (SP) - Snowden-Pencer Diamond-Line (ST-MF,RR, WM-FE,RR); Snowden-Pencer Scissors (WM-FE,RR) Robling1585 (SP) - Misonix Inc. neXus Ultrasonic Surgical Aspirator System EndoTheia11104 (SP,CH1*) - FlexStone Basket AccessPoint5418 (MN) - Map-iT VerathonMedical5877 (WT) - GlideRite Single-Use Stylet - Small VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System US_Endoscopy4223 (SP) - Endoscopic Tip Protector QTI7873 (SP) - Skintestor OMNI Robling1585 (SP) - Fibulink Syndemosis Repair Kit/SS Instylla8045 (SP) - Instylla Microcatheter 1.2 US_Endoscopy4223 (SP) - UroSeal adjustable endoscopic valve (00913410) (EN-CFE) StrykerSustainability (SP) - Hemo-Force Calf Garment Small StrykerSustainability (SP) - Hemo-Force Calf Garment Medium StrykerSustainability (SP) - Hemo-Force Calf Garment Bariatric StrykerSustainability (SP) - Vaso/Hemo Force Foot Garment Medium StrykerSustainability (SP) - Hemo-Force Calf Garment Large StrykerSustainability (SP) - Hemo-Force Thigh Garment Medium StrykerSustainability (SP) - Hemo-Force Thigh Garment Large StrykerSustainability (SP) - Vaso/Hemo Force Foot Garment Large Aquabiliti1563 (SP,GR) - Saline-filled flush syringe ErbeUSA9143 (SP, EP1) - Endo QuickConnect Pentax® Scope Port Connector TransMedics4216 (NR,SP*) - OCS Lung 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 Protech3048 (TM) - PHANTOM ML LIGHT CABLE Remington4376 (SP) - Illumination Systems BD4590 (SP) - BD Vacutainer® Serum Blood Collection Tubes 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 Atrion1619 (SP) - QL Inflation Device Atrion1619 (SP) - Sphere Inflation Device MicroPortOrtho6872 (SP) - Bipolar Shell Instylla8045 (SP) - Instylla Delivery Kit Robling1585 (SP) - AngiAssist Medical Gas Management and Delivery System 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 Design2052 (NR) - CTS Relief Kit US_Endoscopy4223 (SP) - Moray micro forceps US_Endoscopy4223 (SP) - Talon Grasping Device Atrion1619 (SP) - Ql Inflation Dveice Zimmer (LN, LS) - Trauma Fixation Systems Robling1585 (SP) - Fibulink Removal Kit US_Endoscopy4223 (SP) - Lariat snare US_Endoscopy4223 (SP) - Coin Tip Snare Aquabiliti1563 (SP,GR) - Saline, vascular access flush US_Endoscopy4223 (SP) - Torrent irrigation scope connector - Pentax US_Endoscopy4223 (SP) - Torrent irrigation tubing ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Olympus® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid OFP & EndoStat Tubing/Cap Set for Olympus® Scope ErbeUSA9143 (SP,EP1) - ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Olympus® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Fujinon® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Fujifilm® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Pentax® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Pentax® Scopes AdvancedInnovation8660 (SP) - Libertas BiPolar Hip System Robling1585 (SP) - Sample Extraction Tools 230-600 Robling1585 (SP) - Sample Extraction Tools 200-200 Robling1585 (SP) - Sample Extraction Tools 230-400 Robling1585 (SP) - Brushes for Flexible Endoscope Culture Kit BaxterCR10745 (SP) - ONE-LINK StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Bariatric StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Small StrykerSustainability (SP) - Venaflow Elite Foam Calf Cuff Green StrykerSustainability (SP) - Venaflow Elite Calf Cuff Single Hose StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Large StrykerSustainability (SP) - Venaflow Elite XL Calf Cuff Single Hose StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Medium StrykerSustainability (SP) - Plexipulse Foot Wrap StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Medium StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Large StrykerSustainability (SP) - VenaFlow Elite Thigh Cuff Single Hose StrykerSustainability (SP) - enaFlow Foam Calf Cuff Dual Hose StrykerSustainability (SP) - VenaFlow Elite Foot Garment Single Hose StrykerSustainability (SP) - VenaFlow Foot Garment with Pos Lock Up to 16" StrykerSustainability (SP) - Flowtron Thigh Garment Thigh StrykerSustainability (SP) - Foot Garment - One Pair Regular StrykerSustainability (SP) - Alternating Leg Pressure Pair Calf Large StrykerSustainability (SP) - Calf Garment - One Pair Regular StrykerSustainability (SP) - VenaFlow Disposable Thigh Cuff StrykerSustainability (SP) - Vaso Press Calf Compression Sleeve Large up to 24" StrykerSustainability (SP) - VenaFlow Calf Garment with Pos Lock Up to 19" StrykerSustainability (SP) - Foot Sleeve up to 14.5" StrykerSustainability (SP) - Thigh Sleeve Medium StrykerSustainability (SP) - Vaso Press Calf Garment Medium Up to 18" StrykerSustainability (SP) - Alternating Leg Pressure Pair Thigh Regular StrykerSustainability (SP) - Thigh Garment - One Pair Large StrykerSustainability (SP) - Vaso Press Thigh Garment DVT Prophylaxis System Large / up to 36" StrykerSustainability (SP) - Calf Sleeve Medium StrykerSustainability (SP) - VenaFlow Disposable Foot Cuff StrykerSustainability (SP) - Vaso Press Calf Garment Large Up to 24" StrykerSustainability (SP) - Vaso Press Thigh Compression Sleeve Large up to 36" StrykerSustainability (SP) - Thigh Sleeve Large StrykerSustainability (SP) - Impad Rigid Sole Foot Cover Right and Left Foot Large StrykerSustainability (SP) - Calf Sleeve - Pair Fits up to 21 1/2 in Medium StrykerSustainability (SP) - VenaFlow Thigh Garment with Pos Lock Up to 29" StrykerSustainability (SP) - Calf Garment - One Pair Large StrykerSustainability (SP) - SCD Express Compression Sleeve Foot Cuff Regular StrykerSustainability (SP) - Vaso Press Thigh Compression Sleeve Medium up to 29" StrykerSustainability (SP) - Calf Sleeve Short StrykerSustainability (SP) - Alternating Leg Pressure Pair Calf Regular StrykerSustainability (SP) - Vaso Press Foot Garment Large StrykerSustainability (SP) - Calf Sleeve - Pair Large up to 25 1/2" StrykerSustainability (SP) - Vaso Press Foot Garment Foot Size up to US13 StrykerSustainability (SP) - Thigh Sleeve Small StrykerSustainability (SP) - Alternating Leg Pressure Pair Foot Regular Up to 12 EEE StrykerSustainability (SP) - Vaso Press Thigh Garment DVT Prophylaxis System Medium / up to 29" StrykerSustainability (SP) - Thigh Garment - One Pair Regular StrykerSustainability (SP) - VenaFlow Disposable Calf Cuff StrykerSustainability (SP) - Flowtron DVT Calf Garment Calf StrykerSustainability (SP)- Foot Garment - One Pair Large StrykerSustainability (SP) - Foot Garment Universal Large StrykerSustainability (SP) - VenaFlow Disp XL Calf Cuff StrykerSustainability (SP) - Calf Garment - One Pair Extra Large StrykerSustainability (SP) - Calf Sleeve Large StrykerSustainability (SP) - Vaso Press Calf Compression Sleeve Medium up to 18" StrykerSustainability (SP) - Impad Rigid Sole Foot Cover Right and Left Foot Regular StrykerSustainability (SP) - SCD Express Compression Sleeve Foot Cuff Large StrykerSustainability (SP) - VenaFlow XL Calf Garment with Pos Lock Up to 22" US_Endoscopy4223 (SP) - Oracle EUS latex balloon-Olympus radial US_Endoscopy4223 (SP) - Oracle EUS latex balloon-Olympus linear Zimmer (LN,LS) - Bit, drill StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Toggleloc Eagle1350 (NT,SN) - Drill OmegaSurgical (LSRTC) - BIT, DRILL OrchidUnique5936 (LN) - Bit, Drill - Omega ClearChoice10284 (SP) - NPWT Foam Wound Dressing Kits Instylla8045 (SP) - Instylla Microcatheter N8Med6658 (SP) - CeraShield™ Endotracheal Tube AtriCure2121 (SP) - EPi-Sense ST Guided Coagulation System ErbeUSA9143 (SP) - ERBEFLO 2 Endo QuickConnect Scope Port Connectors 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 US_Endoscopy4223 (SP) - Polypectomy Snares MicroPortOrtho6872 (LN,WH,SP) - AXIOM Second Generation Knee System US_Endoscopy4223 (SP) - Infinity Cytology Brush US_Endoscopy4223 (SP) - BioShield Biopsy Valve EUS Robling1585 (SP) - ViaLok Single Vial Access Device Vented US_Endoscopy4223 (SP) - Exacto cold snare Merit1383 (TM) - Worley Slitter Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Contamination Sleeve Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX Remington4376 (SP) - Surgical Cables ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Pentax® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Pentax® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Fujinon® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes & UCR ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Fujifilm® Scopes Robling1585 (SP) - truFreeze Cryo Ablation System Solventum14471 (SP) - 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) Paragon6351 (NR) - Weck EFX Shield Fascial Closure System 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 Remington4376 (SP) - TNMF-XXXX, TNMR-XXXX AtriCure2121 (SP) - AtriCure Dissector Robling1585 (SP) - HBBSD2000 Merit1383 (TM) - ReSolve Locking Drainage Catheter AmericanCatheter5917 (SP) - American Catheter Merit1383 (TM) - Cen-Step Centesis Catheter US_Endoscopy4223 (SP) - Roth Net Retrieval Devices-  Foreign Body Standard US_Endoscopy4223 (SP) - Roth Net Retrieval Devices- Foreign Body Universal US_Endoscopy4223 (SP) - Roth Net Retrieval Devices-Foreign Body Maxi B&LSurgical1668 (SP) - Akreos Single Use Insertion Device B&LSurgical1668 (SP) - Lens Guide, Intraocular US_Endoscopy4223 (SP) - AquaShield System CO2 US_Endoscopy4223 (SP) - AquaShield System-PENTAX US_Endoscopy4223 (SP) - Aquashield System CO2-Fujifilm US_Endoscopy4223 (SP) - AquaShield System CO2-Pentax AtriCure2121 (SP) - Isolator Synergy EnCompass Clamp and Guide System ErbeUSA9143 (SP, EP1) - ERBEFLO® Olympus® Scope Port Connector US_Endoscopy4223 (SP) - Articulator Injection Needle; Carr-Locke Injection Needle WellsLamont8889 (SP) - Wells Lamont Cut Resistant Surgical Glove Liners Femasys4487 (SP) - FemaSeed Intratubal Insemination Robling1585 (SP) - Clip, Implantable, Titanimum Robling1585 (SP) - neXus Ultrasonic Surgical Apirator System US_Endoscopy4223 (SP) - Infinity ERCP sampling device US_Endoscopy4223 (SP) - Histoguide wire-guided forceps US_Endoscopy4223 (SP) - BioShield Biopsy Valve ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes AdvancedInnovations8660 (SP) - Libertas E-XLPE Modular Liner Robling1585 (SP) - Pulse Lavage Systems US_Endoscopy4223 (SP) - Histolock Resection Device CarpusMed (SP) - NAR Compressed Gauze Hydrofera2363 (NR,WH) - Instrument Wipe ZMedica3625 (NR,WH) - Phokus Nonwoven Bandage CarpusMed (SP) - NAR S-Rolled Gauze Hollister (SP) - Urostomy Pouch Hollister (SP) - Center Point Lock; Compact; Conform 2; First Choice; HOLLISTER UROSTOMY BAGS Hollister (SP) - Impression - C; Karaya 5; Moderma Flex; New Image; Premier; Securi-T USA; Tandem Hollister (LN, LS) - Hollister Horizontal Tube Attachment Device BVI1689 (EP1) - Eye Bandage BVI1689 (EP1) - Guibor Eye Bubble Bandage US_Endoscopy4223 (SP) - Defendo Fujifilm 700 series valve kits Anjon7772 (SP) - ANJON BREMER HALO SYSTEM US_Endoscopy4223 (SP) - Padlock Clip Defect Closure System US_Endoscopy4223 (SP) - Padlock Clip Pro-Select Defect Closure System Ensera7760 (SP) - ClarifEye Markers WolfX-Ray11781 (SP) - Steritatt S&N7125 (SP) - NoStingSkinPrep S&N7125 (SP) - Secura S&N7125 (SP) - SecuraNoStingBarrier Robling1585 (SP) - Arisure Dry Spike Hollister (LN, LS) - HOLLISTER STOMA BAGS; Hollister Wound Drainage Collectors; STOMA BAGS Hollister (LN, LS) - A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAINING WOUND MANAGEMENT; Hollister (SP) - New Image; Premier; Securi-T USA; Tandem Hollister (SP) -Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Collectors; First Choice; Hollister (SP) - Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkins; Premier;Restore;Securi-T USA Hollister (SP) - Conform 2; First Choice; HOLLISTER UROSTOMY BAGS; Impression - C; Karaya 5; Moderma Flex Hollister (SP) - HOLLISTER STOMA BAGS; Hollister Wound Drainage Collectors; STOMA BAGS;Center Point Lock; Compact; Hollister (LN,LS,SP) - A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAINING WOUND MANAGEMENT Hollister (SP) - Holligard; Hollister; Hollister Solo Stoma Cap; Invent; Karaya 5; m9; Moderma Flex; New Image; Hollister (SP) - Tandem; Urostomy Drain Tube Adapter; Loop Ostomy Bridge; A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAI Femasys4487 (SP) - FemCath Cornual Ballon Catheter WellsLamont8889 ( SP) - Cut-Tec or Wells Lamont Polyester/Wire Cut Resistant Glove Liner WellsTecSceptert Robling1585 (SP) - Clip, Implantable, Polymer Preferred3038 (SP) - Bag Decanters Atrion1619 (SP) - QL Locking Syringe US_Endoscopy4223 (SP) - Torrent Irrigation Tubing BD4590 (SP) - BD Vacutainer® Serum Separator (SST™) Blood Collection Tube Merit1383 (TM) - BIG60 Merit1383 (TM) -Basix Compak Inflation Device Merit1383 (TM) - BIG60 ALPHA Inlfation Device Femasys4487 (SP) - VariLock Balloon Inflation Syringe McFarlane6051 (SP) - PercuNav Coaxial Needle Tracker US_Endoscopy4223 (SP) - BioGuard Air/Water and Suction valves (00711780) (EN-SD) Robling1585 (SP) - TS3 Robling1585 (SP) - TS3 Sentara US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (3 pc kit) US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (4 pc kit) BVI1689 (EP1) - Beaver Replacement Teflon Block BVI1689 (EP1) - Corneal Trephine US_Endoscopy4223 (SP) - Reveal Distal Attachment Cap Cryolife1999 (SP) - BGST-16 16mm Spreader Tip Cryolife1999 (SP) - BGST-12 12mm Spreader Tip Cryolife1999 (SP) - BG3502 BioGlue 2 mL Cryolife1999 (SP) - BGAT-SY Mixing Tip Artivion10572 (SP) - BG3502 BioGlue 2 mL Artivion10572 (SP) - BG3510 BioGlue 10 mL Cryolife1999 (SP) - BioGlue Surgical Adhesive Artivion10572 (SP) - BG3515 BioGlue 5 mL Artivion10572 (LN,SP) - BG3502 BioGlue Surgical Adhesive, 2mL US_Endoscopy4223 (SP) - Roth Net - foreign body maxi US_Endoscopy4223 (SP) - Roth Net Platinum - polyp US_Endoscopy4223 (SP) - Roth Net retriever - 360 US_Endoscopy4223 (SP) -Roth Net - foreign body mini US_Endoscopy4223 (SP) - Roth Net Platinum - universal US_Endoscopy4223 (SP) - Roth Net - foreign body standard US_Endoscopy4223 (SP) - Roth Net retriever select US_Endoscopy4223 (SP) - Roth Net Retrieval Devices- Pediatric 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 AtriCure2121 (SP) - Isolator Linear Pen AtriCure2121 (SP) - Isolator Transpolar Pen AtriCure2121 (SP) - Coolrail Linear Pen AtriCure2121 (SP) - Isolator Synergy Access Clamp AtriCure2121 (SP) - Isolator Synergy Surgical Ablation System BD4590 (SP) - BD BACTEC™ Subculturing/Aerobic Venting Unit ICU7944 (SP,EP1) - EMPTY CONTAINER 1000mL ICU7944 (SP,EP1) - EMPTY CONTAINER 250mL ICU7944 (SP,EP1) - EMPTY CONTAINER ICU7944 (SP,EP1) - EMPTY CONTAINER 100mL STERIS7139 (SP) - Sterile Handle Camera Cover (LB54) STERIS7139 (SP) - Sterile Light Handle Cover (LB53) STERIS7139 (SP) - Universal Light Handle Cover (LB82) StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK-SOFT TISSUE FIXATION StrykerPR3324 (GR, VG) - ACL DISPOSABLE PACK BONE-TENDON-BONE BVI1689 (EP1) - CustomEyes Acuderm1463 (WH,LS) -Acu-Punch Kit Adhezion5351 (LN,SP) - Floraseal Microbial Sealant HBFuller5351 (LN) - FloraSeal Microbial Sealant Robling1585 (SP) - ONO Retrieval Device Femasys4487 (SP) - FemCerv Endocervical Sampler Atrion1619 (SP) - QL Fluid Dispensing Syringe Preferred3038 (SP) - Equipment Covers US_Endoscopy4223 (SP) - Raptor grasping device - mini US_Endoscopy4223 (SP) - Raptor grasping device Merit1383 (SN) - SafeGuard Focus Compression AdvancedInnovations8660 (SP) - Libertas StrykerPR3324 (GR,LS, VG) - Strykeflow Single Spike Tube Set StrykerPR3324 (GR, LS, VG) - PKG., STRYKEFLOW SUCTION/IRRIGATOR PS StrykerPR3324 (VG,GR) - StrykeFlow PS StrykerPR3324 (VG,GR) - Strykeflow Single Spike Tube Set Solventum14471 (SP) - 3M™ Steri-Drape™ Robling1585 (SP) - Arisure Neutral Valve Remington4376 (SP) - Bag Decanter AtriCure2121 (SP) - Synergy Ablation System Cryolife1999 (SP) - PhotoFix Decellularized Bovine Pericardium Hollister (SP,LS,LN) - Moderma Flex; New Image; Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkin Hollister (LN, LS) - Ostomy Skin Barriers Hollister (SP,LS,LN) - Premier; Restore; Securi-T USA; Suavita; Tandem; Urostomy Drain Tube Adapter Hollister (LN, LS) - Hollister Hollister (SP,LS,LN) - Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Colle Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image TransMedics4216 (NR,SP*) - OCS Heart System TransMedics4216 (NR,SP*) - OCS Liver System StrykerSustainability (SP) - Compression Sleeve Medium Knee < 21" StrykerSustainability (SP) - Compression Sleeve Medium Thigh <28" StrykerSustainability (SP) - Compression Sleeve Large Knee < 26" StrykerSustainability (SP) - Compression Sleeve Small Knee < 14" StrykerSustainability (SP) - Compression Sleeve Small Thigh < 22" StrykerSustainability (SP) - Compression Sleeve Large Thigh <36" StrykerSustainability (SP) - Compression Sleeve Extra Small Thigh < 16" US_Endoscopy4223 (SP) - Articulator injection needle US_Endoscopy4223 (SP) - Carr-Locke injection needle US_Endoscopy4223 (SP) - Short Throw - snare - enteroscope US_Endoscopy4223 (SP) - Traxtion hexagonal snare US_Endoscopy4223 (SP) - Rotator - snare - oval US_Endoscopy4223 (SP) - Rotator - snare - mini-oval 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 PhoenixMed2991 (SP) - Arthrex Vortex Threaded Bone Marrow Recovery Needle Protech3048 (TM) - Falcon Protech3048 (TM) - Awl Protech3048 (TM) - Lightning ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy OFP & EndoStat Pump Tubing/Cap Set ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Back Flow Valve ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Port Connector for Pentax Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Pump Tubing/Cap Set ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Port Connector w/Valve for Olympus Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Channel Adapter ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Port Connector for Olympus Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Pump Tubing/Cap Set for Fujinon Scopes B&L1668 (SP) - Folders and Injectors, intraocular lens BD4590 (SP) - BD Vacutainer® SST Blood Collection Tubes MicroPortOrtho6872 (SP) - ADVANCE® Double High Insert US_Endoscopy4223 (SP) - AquaShield system 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 Orthofix2908 (SP) - PILLAR SA PTC Spacer System Orthofix2908 (SP) - Construx Mini PTC Spacer System Orthofix2908 (SP) - FORZA PTC Spacer System

    Establishment Types

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