BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Sterigenics Costa Rica S.R.L.

    Reg #: 3010432890 · FEI: 3010432890 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    215
    Establishment Types
    1
    Classifications
    46

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    Registration Details

    Registration Name
    Sterigenics Costa Rica S.R.L.
    Registration Number
    3010432890
    FEI Number
    3010432890
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zona Franca PROPARK, Calle Principal, Edificio 10
    City
    El Coyol Alajuela
    Country
    CR

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Hemostatic Metal Clip For The Gi Tract PKL
    Endoscopic Tissue Approximation Device OCW
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN
    System, Irrigation, Urological LJH
    Heart-Valve, Non-Allograft Tissue LWR
    Replacement Heart-Valve DYE
    Heart-Valve, Mechanical LWQ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Stopcock, I.V. Set FMG
    Catheter, Percutaneous DQY
    Syringe, Piston FMF
    Set, I.V. Fluid Transfer LHI
    System, Surgical, Computer Controlled Instrument NAY
    Tube, Aspirating, Flexible, Connecting BYY
    Staple, Implantable GDW
    Catheter, Intravascular, Diagnostic DQO
    Accessories, Catheter KGZ
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Bronchoscope (Flexible Or Rigid) EOQ
    Drape, Surgical, Antimicrobial KKX
    Catheter, Ultrasound, Intravascular OBJ
    Introducer, Catheter DYB
    Stent, Superficial Femoral Artery NIP
    Wire, Guide, Catheter DQX
    Transducer, Pressure, Catheter Tip DXO
    Warmer, Thermal, Infusion Fluid LGZ
    Insufflator, Hysteroscopic HIG
    Arthroscope HRX
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Gown, Surgical FYA
    Instrument, Ultrasonic Surgical LFL
    Hood, Surgical FXY
    Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss QTD
    Stapler, Surgical GAG
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Transducer, Ultrasonic, Diagnostic ITX
    Laparoscope, General & Plastic Surgery GCJ
    Dispenser, Liquid Medication KYX
    Tubing And Tubing/Filter Fits NVT
    Catheter, Intravascular Occluding, Temporary MJN
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Set, Blood Transfusion BRZ
    Set, Transfer (Blood/Plasma) KSB
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Stent, Carotid NIM

    Proprietary Names

    Stopcock 3 Way 3-Way Stopcock HBO Pass Through Headway Microcatheters SP1098 Entry Guide - 430022 da Vinci Xi Instrument Arm Drape Instrument Arm Drape Xi Instrument Arm Drape - 470015 Xi Column Drape - 470341 Suction conneting tube Aspiration Tubing 8MM Sureform 30 Reload, White - 48230W 8MM Sureform 30 Reload, Gray - 48230M 8MM Sureform 30 Reload, Blue - 48230B 8MM Sureform 30 Instrument, Curved Tip - 488530 8MM Sureform 30 Instrument, Straight Tip - 488430 Microcatheter Headway Duo OverStitch™ Endoscopic Suturing System and Accessories Sofia Catheters ABLATION PROBE, MW ABLATION, IF1000 - 490130 Argon Angiography Drape OR Towel, Drapes Column Drape KP11827/250 IS4200 Arm 4 Proximal Drape - 470473 IF1000 Vision Probe Bag - 490127 SP Camera Instrument Sheath - 430020 SP Drape - 430013 SP Instrument Sheath - 430012 SP Monopolar Scissors Tip - 430035 Guidewire Traxcess 14 Xi Suction/Irrigator - 480299 SureForm™ 45 (Stapler 45) Reload (White) - 48345W SureForm™ 45 (Stapler 45) Reload (Green) - 48345G SureForm™ 45 (Stapler 45) Reload (Black) - 48345T SureForm™ 45 (Stapler 45) Reload (Blue) - 48345B SureForm™ 45 (Stapler 45) Reload (Grey) - 48345M SureForm™ 45 (Stapler 45) Straight-Tip Instrument - 480445 FluidSmart Urology Tube Set FluidSmart Inflow Tube Set PAT OUTFLOW SET INFLOW SET FluidSmart Inflow Outflow Tube Set Microcatheter Headway 17 Advanced Guidewire Traxcess 14EX Microcatheter Headway 21 INSPIRIS RESILIA Aortic Valve Edwards Pericardial Aortic Bioprosthesis MITRIS RESILIA Mitral Valve INSPIRIS 11500A (RESILIA Process) T4 PULLOVER TOGA, L T4 PULLOVER TOGA, L/XL T5 PULLOVER TOGA W/ PEELAWAY T4 ZIPPER TOGA W/INSIDE T4 ZIPPER TOGA, L T4 ZIPPER TOGA W/T3 CUT T4 ZIPPER TOGA, XL T4 HOOD W/BLUE STERILE WRAP T4 ZIPPER TOGA (L/XL) (10/PKG) T5 ZIPPER TOGA W/ PEELAWAY T4 ZIPPER TOGA, REGULAR T4 ZIPPER TOGA, S/M T4 HOOD EXTENDED LENGTH T5 HOOD W/ PEELAWAY FACE T4 PULLOVER TOGA, REGULAR T4 PULLOVER TOGA, S/M T4 PULLOVER TOGA, XL T4 HOOD (36/PKG) T4 HOOD W/PEEL POUCH Guidewire Traxcess Docking Wire Xi Harmonic ACE - 480275 Neptune E-SEP Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch Neptune E-SEP Smoke Evacuation Pencil, Coated, 70mm Blade, Rocker Switch Xi 8mm Synchroseal - 480440 Xi Conductive Reducer - 470381 Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09) Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07) Si Stapler Sheath - 410370 Xi Stapler 45 Reload (Blue) - 48645B Xi Seal (12mm & Stapler) - 470380 12 mm & Stapler Cannula Seal - 470380 Xi Stapler 45 Reload (White) - 48645W Xi Stapler 45 Reload (Green) - 48445G Burette Set Stapler Reload SureForm™ 45 (Blue) - 48245B SureForm™ 45 (Stapler 45) Curved-Tip Instrument - 480545 Si Harmonic ACE Insert - 400272 TREK OTW Dilatation Catheter NC TREK RX Dilatation Catheter NC TREK OTW Dilatation Catheter Mini Trek RX Dilatation Catheter TREK RX Dilatation Catheter MINI TREK II OTW Dilatation Catheter 23GBiopsy Needle,IF1000 - 490102 Vision Probe Adapter - 490101 Swivel Connector - 490108 19G Biopsy Needle,IF1000 - 490104 21G Biopsy Needle,IF1000 - 490103 FLYTE SURGICOOL HOOD W/PEELAWAY FLYTE SURGICOOL HOOD (28/CS) 0408-801-400 Flyte SurgiCool Hood 0408-801-500 Flyte SurgiCool Hood, Peelaway ASSY,FENESTRATED BIPOLAR FORCEPS,SINGLE SITE,6-PAK (PN 428093-13) Xi Single Site Fenestrated Bipolar Forceps - 478093 Xi Single Site Bipolar Maryland - 478080 Xi Single-Site Cannula Seal - 478161 Xi Single-Site Port - 478065 Xi Stapler 30 Reload (Blue) - 48630B Xi Stapler 30 Reload (Green) - 48630G Xi Stapler 30 Reload (White) - 48630W Xi Stapler 30 Reload (Gray) - 48630M Si Cannula Seal - 400077 Si Cautery Spatula, A-Sure (5mm) - 400160 SUPRA CORE Guide Wire Microcatheter Headway 27 Si MCS Tip Cover Accessory (8mm) - 400180 SureForm™ 60 (Stapler 60) Reload (White) - 48360W SureForm™ 60 (Stapler 60) Reload (Black) - 48360T SureForm™ 60 (Stapler 60) Reload (Blue) - 48360B SureForm™ 60 (Stapler 60) Instrument - 480460 SureForm™ 60 (Stapler 60) Reload (Green) - 48360G FluidSmart Thermaclear VOYAGER NC Dilatation Catheter FLYTE TOGA, PULLOVER XL FLYTE SURGICOOL TOGA, ZIPPER 3X FLYTE SURGICOOL TOGA, PULLOVER, 3X FLYTE SURGICOOL TOGA, PULLOVER, XL FLYTE SURGICOOL TOGA, ZIPPER FLYTE SURGICOOL TOGA, Zipper PEELAWAY, L FLYTE SURGICOOL TOGA, PULLOVER, 2X FLYTE SURGICOOL TOGA, PEELAWAY, 2X FLYTE SURGICOOL TOGA, ZIPPER, 2X FLYTE SURGICOOL TOGA, ZIPPER, L FLYTE SURGICOOL TOGA, PEELAWAY, 3X FLYTE SURGICOOL TOGA, PEELAWAY FLYTE SURGICOOL TOGA, PULLOVER, L 0408-841-100 Flyte Surgicool Toga, 2XL, Zipper, Peelaway 0408-851-000 Flyte Surgicool Toga, 3XL, Zipper 0408-821-100 Flyte Surgicool Toga, L, Zipper, Peelaway 0408-831-000 Flyte Surgicool Toga, XL, Zipper 0408-851-100 Flyte Surgicool Toga, 3XL, Zipper, Peelaway 0408-821-000 Flyte Surgicool Toga, L, Zipper 0408-741-000 Flyte Surgicool Toga, 2XL, Pullover 0408-751-000 Flyte Surgicool Toga, 3XL, Pullover 0408-831-100 Flyte Surgicool Toga, XL, Zipper, Peelaway 0408-841-000 Flyte Surgicool Toga, 2XL, Zipper 0408-731-000 Flyte Surgicool Toga, XL, Pullover Scepter Balloons Edwards Certitude Introducer Sheath Set Edwards Crimper Edwards Commander Delivery System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Certitude Delivery System eSheath- 914ES eSheath- 916ES Edwards eSheath Introducer Set- 914ES Edwards eSheath Introducer Set- 916ES Edwards SAPIEN 3 Ultra Delivery System Edwards Axela Sheath Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Microcatheter Headway 17 Advanced (Soft) Xi Vessel Sealer - 480422 VERSACORE Guide Wire FLYTE TOGA, PULLOVER, L FLYTE TOGA, ZIPPER, L FLYTE TOGA, PULLOVER, 3X FLYTE TOGA, PULLOVER, 2X FLYTE TOGA, ZIPPER, 3X FLYTE TOGA, ZIPPER, XL FLYTE TOGA, PEELAWAY XL FLYTE TOGA, ZIPPER, 2X FLYTE TOGA, PEELAWAY, L FLYTE TOGA PEELAWAY, 3X FLYTE TOGA, PEELAWAY, 2X ALL STAR 14 0416-831-100 T7Plus Zippered Toga with Peel Away 0416-841-200 T7Plus Zippered Toga 0416-750-200 T7 Pullover Toga 0416-820-200 T7 Zippered Toga 0416-821-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-830-100 T7 Zippered Toga with Peel Away Face Shield 0416-730-200 T7 Pullover Toga 0416-801-200 T7Plus Hood 0416-801-000 T7Plus Hood with Standard Face Shield 0416-851-200 T7Plus Zippered Toga 0416-731-200 T7Plus Pullover Toga 0416-851-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-830-200 T7 Zippered Toga 0416-841-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-751-200 T7Plus Pullover Toga 0416-820-100 T7 Zippered Toga with Peel Away Face Shield 0416-850-200 T7 Zippered Toga 0416-831-200 T7Plus Zippered Toga 0416-850-100 T7 Zippered Toga with Peel Away Face Shield 0416-740-200 T7 Pullover Toga 0416-741-200 T7Plus Pullover Toga 0416-800-200 T7 Hood 0416-801-100 T7Plus Hood with Peel Away Face Shield 0416-821-200 T7Plus Zippered Toga 0416-721-200 T7Plus Pullover Toga 0416-840-200 T7 Zippered Toga 0416-840-100 T7 Zippered Toga with Peel Away Face Shield 0416-800-100 T7 Hood with Peel Away Face Shield Si Cautery Hook, A-Sure (5mm) - 400156 Xact Stent System FLYTE HOOD W/PEELAWAY FLYTE PEELAWAY HOOD W/ WRAP Flyte Extended Hood w/Peelaway Flyte Extended Hood FLYTE HOOD SP Access Port Kit, 2.7 - 4 cm - 430073 SP Access Port Kit, 2.7 - 4 cm SP Access Port Kit, 2.7 - 7 cm SP Access Port Kit, 2.7 - 7 cm - 430075

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)