MedtechSourcebook

Sterigenics U.S., LLC

Contract sterilizer · Santa Teresa, NM

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1721686 (openFDA record; or search FDA's registration database)
FEI number
1721686
Registered for
FDA registration year 2026
Establishment types
Contract sterilizer
Owner or operator
Sotera Health LLC (FDA owner/operator no. 10029425)
Registered address
2400 Airport Rd, Santa Teresa, NM 88008
Contract listings
207 device listings, 99 product codes, first listed May 13, 2009
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
BSRStylet, Tracheal TubeClass IAnesthesiologyContract sterilizationJul 1, 2013
BTGBrush, Biopsy, Bronchoscope (Non-Rigid)Class IIEar, nose and throatContract sterilizationJul 12, 2013
BTOTube, Tracheostomy (W/Wo Connector)Class IIAnesthesiologyContract sterilizationJun 6, 2013
BTQAirway, NasopharyngealClass IAnesthesiologyContract sterilizationNov 20, 2012
BTRTube, Tracheal (W/Wo Connector)Class IIAnesthesiologyContract sterilizationNov 20, 2012
BYEAttachment, Breathing, Positive End Expiratory PressureClass IIAnesthesiologyContract sterilizationJun 6, 2013
BZTStethoscope, Esophageal, With Electrical ConductorsClass IIAnesthesiologyContract sterilizationJun 6, 2013
DQKComputer, Diagnostic, ProgrammableClass IICardiovascularContract sterilizationOct 31, 2019
DQOCatheter, Intravascular, DiagnosticClass IICardiovascularContract sterilizationJul 12, 2013
DQXWire, Guide, CatheterClass IICardiovascularContract sterilizationJun 14, 2012
DQYCatheter, PercutaneousClass IICardiovascularContract sterilizationJun 7, 2013
DRBStylet, CatheterClass IICardiovascularContract sterilizationMar 16, 2023
DREDilator, Vessel, For Percutaneous CatheterizationClass IICardiovascularContract sterilizationNov 12, 2012
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingClass IICardiovascularContract sterilizationOct 31, 2019
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyClass IICardiovascularContract sterilizationJun 14, 2012
DTKFilter, Intravascular, CardiovascularClass IICardiovascularContract sterilizationJun 7, 2021
DXECatheter, EmbolectomyClass IICardiovascularContract sterilizationJun 7, 2013
DXOTransducer, Pressure, Catheter TipClass IICardiovascularContract sterilizationJun 14, 2012
DXTInjector And Syringe, AngiographicClass IICardiovascularContract sterilizationJul 15, 2013
DYBIntroducer, CatheterClass IICardiovascularContract sterilizationNov 13, 2012
EAJApron, LeadedClass IRadiologyContract sterilizationJun 25, 2026
EOQBronchoscope (Flexible Or Rigid)Class IIEar, nose and throatContract sterilizationJul 12, 2013
EYAStylet, UreteralClass IGastroenterology and urologyContract sterilizationApr 9, 2020
EYXDrape, Pure Latex Sheet, With Self-Retaining Finger CotClass IIGeneral and plastic surgeryContract sterilizationJun 25, 2025
EYYDrape, Urological, DisposableClass IIGeneral and plastic surgeryContract sterilizationJun 13, 2023
EZLCatheter, Retention Type, BalloonClass IIGastroenterology and urologyContract sterilizationJul 7, 2017
FCGBiopsy NeedleClass IIGastroenterology and urologyContract sterilizationDec 14, 2012
FDISnare, FlexibleClass IIGastroenterology and urologyContract sterilizationJul 12, 2013
FDXEndoscopic Cytology BrushClass IIGastroenterology and urologyContract sterilizationJul 12, 2013
FEHElectrode, Flexible Suction CoagulatorClass IIGastroenterology and urologyContract sterilizationJul 12, 2013
FLLContinuous Measurement ThermometerClass IIGeneral hospitalContract sterilizationJun 6, 2013
FMINeedle, Hypodermic, Single LumenClass IIGeneral hospitalContract sterilizationJun 7, 2013
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysClass IIGeneral hospitalContract sterilizationJun 7, 2013
FPASet, Administration, IntravascularClass IIGeneral hospitalContract sterilizationMay 10, 2013
FQMBandage, ElasticClass IGeneral hospitalContract sterilizationMay 13, 2009
FRLFiber, Medical, AbsorbentClass IGeneral hospitalContract sterilizationNov 15, 2012
FRNPump, InfusionClass IIGeneral hospitalContract sterilizationOct 24, 2012
FSHTray, Surgical, NeedleClass IGeneral and plastic surgeryContract sterilizationDec 14, 2012
FSMTray, Surgical, InstrumentClass IGeneral and plastic surgeryContract sterilizationNov 15, 2012
FXYHood, SurgicalClass IIGeneral and plastic surgeryContract sterilizationAug 10, 2017
FYAGown, SurgicalClass IIGeneral and plastic surgeryContract sterilizationDec 4, 2012
GAANeedle, Aspiration And Injection, DisposableClass IGeneral and plastic surgeryContract sterilizationJul 12, 2013
GAGStapler, SurgicalClass IIGeneral hospitalContract sterilizationOct 26, 2022
GCBNeedle, CatheterClass IGeneral and plastic surgeryContract sterilizationDec 17, 2012
GDTStaple, Removable (Skin)Class IGeneral and plastic surgeryContract sterilizationJul 31, 2013
GDWStaple, ImplantableClass IIGeneral and plastic surgeryContract sterilizationJul 5, 2017
GEEBrush, Biopsy, General & Plastic SurgeryClass IGeneral and plastic surgeryContract sterilizationJul 12, 2013
GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass IIGeneral and plastic surgeryContract sterilizationJul 12, 2013
HGIElectrocautery, Gynecologic (And Accessories)Class IIObstetrics and gynecologyContract sterilizationMay 18, 2021
HGXPump, Breast, PoweredClass IIObstetrics and gynecologyContract sterilizationDec 27, 2012
HGYPump, Breast, Non-PoweredClass IObstetrics and gynecologyContract sterilizationDec 27, 2012
HHKCurette, Suction, Endometrial (And Accessories)Class IIObstetrics and gynecologyContract sterilizationJun 4, 2013
HMTDrape, Patient, OphthalmicClass IIGeneral and plastic surgeryContract sterilizationSep 5, 2025
HMWDrape, Microscope, OphthalmicClass IIGeneral and plastic surgeryContract sterilizationSep 5, 2025
HRXArthroscopeClass IIOrthopedicContract sterilizationJul 15, 2013
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass IIRadiologyContract sterilizationJun 25, 2026
JDCProsthesis, Elbow, Constrained, CementedClass IIOrthopedicContract sterilizationJun 7, 2013
JOHTube Tracheostomy And Tube CuffClass IIAnesthesiologyContract sterilizationJun 6, 2013
JOLCatheter And Tip, SuctionClass IIGeneral hospitalContract sterilizationJun 7, 2013
KDDKit, Surgical Instrument, DisposableClass IGeneral and plastic surgeryContract sterilizationJun 7, 2013
KGWRing (Wound Protector), Drape Retention, InternalClass IIGeneral and plastic surgeryContract sterilizationSep 5, 2025
KGXTape And Bandage, AdhesiveClass IGeneral hospitalContract sterilizationNov 12, 2012
KKXDrape, Surgical, AntimicrobialClass IIGeneral and plastic surgeryContract sterilizationDec 4, 2012
KNWInstrument, BiopsyClass IIGastroenterology and urologyContract sterilizationDec 17, 2012
KODCatheter, UrologicalClass IIGastroenterology and urologyContract sterilizationJun 6, 2013
KRACatheter, Continuous FlushClass IICardiovascularContract sterilizationJun 25, 2026
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass IIOrthopedicContract sterilizationJun 5, 2025
LDFElectrode, Pacemaker, TemporaryClass IICardiovascularContract sterilizationOct 31, 2019
LFJCatheter, SubclavianClass IIGastroenterology and urologyContract sterilizationJun 7, 2013
LFLInstrument, Ultrasonic SurgicalUnclassifiedGeneral and plastic surgeryContract sterilizationDec 5, 2023
LITCatheter, Angioplasty, Peripheral, TransluminalClass IICardiovascularContract sterilizationNov 13, 2012
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysClass IIGeneral hospitalContract sterilizationJun 7, 2013
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUnclassifiedGastroenterology and urologyContract sterilizationJul 22, 2013
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousClass IICardiovascularContract sterilizationJul 12, 2013
LPBCardiac Ablation Percutaneous CatheterClass IIICardiovascularContract sterilizationOct 31, 2019
LROGeneral Surgery TrayClass IIGeneral and plastic surgeryContract sterilizationNov 9, 2012
LRPTray, SurgicalClass IGeneral and plastic surgeryContract sterilizationNov 30, 2012
LYUAccessory, Surgical ApparelClass IGeneral and plastic surgeryContract sterilizationJun 8, 2021
MAVSyringe, Balloon InflationClass IICardiovascularContract sterilizationJul 15, 2013
MGBDevice, Hemostasis, VascularClass IIICardiovascularContract sterilizationMay 1, 2013
MIANeedle, Spinal, Short TermClass IIAnesthesiologyContract sterilizationNov 21, 2012
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentClass IIICardiovascularContract sterilizationJun 5, 2025
MMZTable, Cystometric, ElectricClass IIGastroenterology and urologyContract sterilizationJun 25, 2026
MTDCatheter, Intracardiac Mapping, High-Density ArrayClass IICardiovascularContract sterilizationJun 7, 2021
NACDressing, Wound, HydrophilicClass IGeneral and plastic surgeryContract sterilizationFeb 4, 2013
NAYSystem, Surgical, Computer Controlled InstrumentClass IIGastroenterology and urologyContract sterilizationJul 5, 2017
NEYSystem, Ablation, Microwave And AccessoriesClass IIGeneral and plastic surgeryContract sterilizationJun 5, 2025
NIPStent, Superficial Femoral ArteryClass IIICardiovascularContract sterilizationNov 29, 2012
OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterClass IIICardiovascularContract sterilizationOct 31, 2019
OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationClass IIICardiovascularContract sterilizationOct 31, 2019
OBJCatheter, Ultrasound, IntravascularClass IICardiovascularContract sterilizationJun 25, 2026
OCYEndoscopic Guidewire, Gastroenterology-UrologyClass IIGastroenterology and urologyContract sterilizationApr 9, 2020
OMPNegative Pressure Wound Therapy Powered Suction PumpClass IIGeneral and plastic surgeryContract sterilizationJul 15, 2013
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentClass IIICardiovascularContract sterilizationJan 14, 2019
PNDMidline CatheterClass IIGeneral hospitalContract sterilizationMar 16, 2023
PUIDrape, Surgical, ExemptClass IIGeneral and plastic surgeryContract sterilizationMar 2, 2018
QJPCatheter, Percutaneous, NeurovasculatureClass IICardiovascularContract sterilizationJun 25, 2026
QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationClass IIICardiovascularContract sterilizationJun 25, 2026
QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic LesionsClass IIICardiovascularContract sterilizationJun 5, 2025

Other contract facilities of Sotera Health LLC