MedtechSourcebook

Sterigenics US LLC

Contract sterilizer · Charlotte, NC

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

FDA registration
1058584 (openFDA record; or search FDA's registration database)
FEI number
1000219637
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Contract sterilizer
Owner or operator
Sotera Health LLC (FDA owner/operator no. 10029425)
Registered address
10811 Withers Cove Park Drive, Charlotte, NC 28278
Contract listings
325 device listings, 208 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
BTOTube, Tracheostomy (W/Wo Connector)Class IIAnesthesiologyContract sterilizationMar 21, 2017
BYDCondenser, Heat And Moisture (Artificial Nose)Class IAnesthesiologyContract sterilizationNov 15, 2012
BYXTubing, Pressure And AccessoriesClass IAnesthesiologyContract sterilizationDec 14, 2012
CAKMicrofilter, Blood TransfusionClass IIGeneral hospitalContract sterilizationNov 30, 2012
CBHDevice, Fixation, Tracheal TubeClass IAnesthesiologyContract sterilizationApr 26, 2017
DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.Class IIClinical toxicologyContract sterilizationJun 29, 2016
DQKComputer, Diagnostic, ProgrammableClass IICardiovascularContract sterilizationJul 16, 2020
DQOCatheter, Intravascular, DiagnosticClass IICardiovascularContract sterilizationJun 28, 2013
DQYCatheter, PercutaneousClass IICardiovascularContract sterilizationDec 10, 2012
DRCTrocarClass IICardiovascularContract sterilizationAug 12, 2015
DSKComputer, Blood-PressureClass IICardiovascularContract sterilizationJul 16, 2020
DWSInstruments, Surgical, CardiovascularClass ICardiovascularContract sterilizationNov 19, 2012
DXTInjector And Syringe, AngiographicClass IICardiovascularContract sterilizationJun 29, 2016
DZPInstrument, Diamond, DentalClass IDentalContract sterilizationNov 8, 2012
EFNCotton, RollClass IDentalContract sterilizationJul 26, 2013
EFQGauze/Sponge, InternalUnclassifiedGeneral and plastic surgeryContract sterilizationMay 30, 2013
EJLBur, DentalClass IDentalContract sterilizationNov 8, 2012
EJQWheel, Polishing AgentClass IDentalContract sterilizationAug 18, 2017
EMFKnife, SurgicalClass IGeneral and plastic surgeryContract sterilizationNov 22, 2022
EQJBur, Ear, Nose And ThroatClass IEar, nose and throatContract sterilizationApr 18, 2013
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceClass IIEar, nose and throatContract sterilizationNov 13, 2020
EXEProtector, OstomyClass IGastroenterology and urologyContract sterilizationDec 9, 2016
EYHTable, Cysto, Non-ElectricalClass IGastroenterology and urologyContract sterilizationJun 28, 2013
EZLCatheter, Retention Type, BalloonClass IIGastroenterology and urologyContract sterilizationNov 14, 2012
EZPRod, ColostomyClass IIGastroenterology and urologyContract sterilizationApr 23, 2013
FCGBiopsy NeedleClass IIGastroenterology and urologyContract sterilizationDec 14, 2012
FCLForceps, Biopsy, Non-ElectricClass IGastroenterology and urologyContract sterilizationMar 21, 2017
FFLDislodger, Stone, Basket, Ureteral, MetalClass IIGastroenterology and urologyContract sterilizationJan 24, 2019
FGEStents, Drains And Dilators For The Biliary DuctsClass IIGastroenterology and urologyContract sterilizationDec 10, 2012
FHQHolder, Needle, GastroenterologicClass IGastroenterology and urologyContract sterilizationJul 11, 2013
FMFSyringe, PistonClass IIGeneral hospitalContract sterilizationNov 30, 2012
FMHContainer, Specimen, SterileClass IPathologyContract sterilizationJun 11, 2010
FMINeedle, Hypodermic, Single LumenClass IIGeneral hospitalContract sterilizationAug 14, 2017
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureClass IIGeneral and plastic surgeryContract sterilizationMar 22, 2017
FMPProtector, Skin PressureClass IGeneral hospitalContract sterilizationNov 12, 2012
FMQRestraint, ProtectiveClass IGeneral hospitalContract sterilizationFeb 24, 2020
FONBag, Drainage, With Adhesive, OstomyClass IGastroenterology and urologyContract sterilizationJun 28, 2013
FPYSheet, BurnClass IGeneral hospitalContract sterilizationOct 29, 2012
FQHLavage, JetClass IIGeneral hospitalContract sterilizationOct 31, 2012
FQMBandage, ElasticClass IGeneral hospitalContract sterilizationMay 13, 2009
FQZThermometer, Clinical Color ChangeClass IGeneral hospitalContract sterilizationMar 26, 2014
FRLFiber, Medical, AbsorbentClass IGeneral hospitalContract sterilizationNov 15, 2012
FRNPump, InfusionClass IIGeneral hospitalContract sterilizationOct 29, 2012
FRODressing, Wound, DrugUnclassifiedGeneral and plastic surgeryContract sterilizationOct 31, 2012
FSHTray, Surgical, NeedleClass IGeneral and plastic surgeryContract sterilizationDec 14, 2012
FSMTray, Surgical, InstrumentClass IGeneral and plastic surgeryContract sterilizationNov 15, 2012
FTALight, Surgical, AccessoriesClass IIGeneral and plastic surgeryContract sterilizationApr 26, 2017
FTLMesh, Surgical, PolymericClass IIGeneral and plastic surgeryContract sterilizationJun 20, 2017
FWZOperating Room Accessories Table TrayClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
FXXMask, SurgicalClass IIGeneral and plastic surgeryContract sterilizationApr 23, 2013
FYAGown, SurgicalClass IIGeneral and plastic surgeryContract sterilizationApr 23, 2013
FYDApparatus, Exhaust, SurgicalClass IIGeneral and plastic surgeryContract sterilizationJun 20, 2017
FYEDress, SurgicalClass IGeneral and plastic surgeryContract sterilizationJun 20, 2017
FZTCutter, SurgicalClass IGeneral and plastic surgeryContract sterilizationNov 30, 2012
FZWExpander, Surgical, Skin GraftClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
GABNeedle, Suturing, DisposableClass IGeneral and plastic surgeryContract sterilizationOct 30, 2012
GACRasp, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract sterilizationOct 31, 2012
GAGStapler, SurgicalClass IIGeneral hospitalContract sterilizationOct 29, 2012
GALSuture, Absorbable, NaturalClass IIGeneral and plastic surgeryContract sterilizationFeb 27, 2018
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidClass IIGeneral and plastic surgeryContract sterilizationOct 31, 2012
GAOSuture, NonabsorbableClass IIGeneral and plastic surgeryContract sterilizationFeb 27, 2018
GAPSuture, Nonabsorbable, SilkClass IIGeneral and plastic surgeryContract sterilizationFeb 27, 2018
GARSuture, Nonabsorbable, Synthetic, PolyamideClass IIGeneral and plastic surgeryContract sterilizationFeb 27, 2018
GATSuture, Nonabsorbable, Synthetic, PolyethyleneClass IIGeneral and plastic surgeryContract sterilizationFeb 27, 2018
GBXCatheter, IrrigationClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
GCJLaparoscope, General & Plastic SurgeryClass IIGastroenterology and urologyContract sterilizationApr 19, 2013
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredClass IGeneral and plastic surgeryContract sterilizationOct 23, 2012
GCZRetainer, SurgicalClass IGeneral and plastic surgeryContract sterilizationNov 30, 2012
GDIDissector, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract sterilizationNov 1, 2012
GDTStaple, Removable (Skin)Class IGeneral and plastic surgeryContract sterilizationJul 31, 2013
GDWStaple, ImplantableClass IIGeneral and plastic surgeryContract sterilizationOct 29, 2012
GDXScalpel, One-PieceClass IGeneral and plastic surgeryContract sterilizationNov 30, 2012
GDYGauze/Sponge, Internal, X-Ray DetectableClass IGeneral and plastic surgeryContract sterilizationNov 15, 2012
GEACannula, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract sterilizationNov 1, 2012
GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass IIGeneral and plastic surgeryContract sterilizationApr 23, 2013
GESBlade, ScalpelClass IGeneral and plastic surgeryContract sterilizationNov 15, 2012
GETMotor, Surgical Instrument, Pneumatic PoweredClass IGeneral and plastic surgeryContract sterilizationApr 19, 2013
GEXPowered Laser Surgical InstrumentClass IIGeneral and plastic surgeryContract sterilizationFeb 27, 2018
GEYMotor, Surgical Instrument, Ac-PoweredClass IGeneral and plastic surgeryContract sterilizationNov 14, 2012
GFABlade, Saw, General & Plastic Surgery, SurgicalClass IGeneral and plastic surgeryContract sterilizationOct 31, 2012
GFDDermatomeClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
GFFBur, Surgical, General & Plastic SurgeryClass IGeneral and plastic surgeryContract sterilizationJan 8, 2013
GFGBit, SurgicalClass IGeneral and plastic surgeryContract sterilizationApr 18, 2013
GIMTubes, Vacuum Sample, With AnticoagulantClass IIClinical chemistryContract sterilizationMar 21, 2013
HBBMotor, Drill, PneumaticClass IINeurologyContract sterilizationNov 13, 2020
HBCMotor, Drill, ElectricClass IINeurologyContract sterilizationNov 13, 2020
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Class IINeurologyContract sterilizationNov 14, 2012
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Class IINeurologyContract sterilizationNov 14, 2012
HDAForceps, ObstetricalClass IIObstetrics and gynecologyContract sterilizationFeb 27, 2018
HETLaparoscope, Gynecologic (And Accessories)Class IIObstetrics and gynecologyContract sterilizationFeb 27, 2018
HFXClamp, CircumcisionClass IIObstetrics and gynecologyContract sterilizationFeb 26, 2018
HJKLens, Contact, Polymethylmethacrylate, DiagnosticClass IIOphthalmicContract sterilizationNov 25, 2014
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Class IOphthalmicContract sterilizationOct 29, 2012
HPZImplant, Eye SphereClass IIOphthalmicContract sterilizationApr 29, 2021
HQCUnit, PhacofragmentationClass IIOphthalmicContract sterilizationFeb 13, 2018
HQNConformer, OphthalmicClass IIOphthalmicContract sterilizationApr 29, 2021
HRPPen, Marking, SurgicalClass IOphthalmicContract sterilizationApr 26, 2017
HRSPlate, Fixation, BoneClass IIOrthopedicContract sterilizationJan 15, 2018
HRXArthroscopeClass IIOrthopedicContract sterilizationApr 17, 2013
HSBRod, Fixation, Intramedullary And AccessoriesClass IIOrthopedicContract sterilizationMar 8, 2017
HSPSplint, TractionClass IOrthopedicContract sterilizationOct 29, 2012
HSTApparatus, Traction, Non-PoweredClass IOrthopedicContract sterilizationJun 28, 2013
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentClass IGeneral and plastic surgeryContract sterilizationJan 25, 2018
HTNWasher, Bolt NutClass IIOrthopedicContract sterilizationApr 18, 2013
HTOReamerClass IOrthopedicContract sterilizationDec 4, 2012
HTRRaspClass IGeneral and plastic surgeryContract sterilizationJan 25, 2018
HTSKnife, OrthopedicClass IOrthopedicContract sterilizationJun 28, 2013
HTTBurr, OrthopedicClass IOrthopedicContract sterilizationOct 31, 2012
HTWBit, DrillClass IOrthopedicContract sterilizationNov 1, 2012
HTYPin, Fixation, SmoothClass IIOrthopedicContract sterilizationOct 31, 2012
HWCScrew, Fixation, BoneClass IIOrthopedicContract sterilizationOct 31, 2012
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentClass IGeneral and plastic surgeryContract sterilizationApr 17, 2013
HWTTemplateClass IOrthopedicContract sterilizationJul 17, 2013
HWXTap, BoneClass IOrthopedicContract sterilizationMay 3, 2013
ILOPack, Hot Or Cold, Water CirculatingClass IIPhysical medicineContract sterilizationApr 23, 2013
IOYSupport, ArmClass IPhysical medicineContract sterilizationMar 19, 2013
ITXTransducer, Ultrasonic, DiagnosticClass IIRadiologyContract sterilizationJun 28, 2013
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass IIRadiologyContract sterilizationNov 13, 2020
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass IIRadiologyContract sterilizationJun 20, 2017
IZQInjector, Contrast Medium, AutomaticClass IICardiovascularContract sterilizationJun 8, 2026
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedClass IIOrthopedicContract sterilizationApr 23, 2013
JDQCerclage, FixationClass IIOrthopedicContract sterilizationMar 20, 2013
JDRStaple, Fixation, BoneClass IIOrthopedicContract sterilizationApr 18, 2013
JDSNail, Fixation, BoneClass IIOrthopedicContract sterilizationMay 21, 2026
JDZMixer, Cement, For Clinical UseClass IOrthopedicContract sterilizationOct 29, 2012
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClass IIClinical chemistryContract sterilizationMar 21, 2013
JOHTube Tracheostomy And Tube CuffClass IIAnesthesiologyContract sterilizationMar 22, 2017
JOSElectrode, ElectrosurgicalClass IIGeneral and plastic surgeryContract sterilizationApr 23, 2013
JRMFreezerClass IClinical chemistryContract sterilizationApr 23, 2013
KBJCurette, AdenoidClass IEar, nose and throatContract sterilizationJun 28, 2013
KCGDilator, TrachealClass IEar, nose and throatContract sterilizationApr 26, 2017
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass IIGeneral hospitalContract sterilizationNov 22, 2022
KCYTourniquet, PneumaticClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
KDCInstrument, Surgical, DisposableClass IGeneral and plastic surgeryContract sterilizationNov 1, 2012
KDDKit, Surgical Instrument, DisposableClass IGeneral and plastic surgeryContract sterilizationMay 13, 2009
KDGChisel (Osteotome)Class IGeneral and plastic surgeryContract sterilizationMar 16, 2018
KDJSet, Administration, For Peritoneal Dialysis, DisposableClass IIGastroenterology and urologyContract sterilizationOct 30, 2012
KGNWound Dressing With Animal-Derived Material(S)UnclassifiedGeneral and plastic surgeryContract sterilizationFeb 26, 2018
KGXTape And Bandage, AdhesiveClass IGeneral hospitalContract sterilizationNov 12, 2012
KJFSystem, Suspension, Cell CultureClass IHematologyContract sterilizationNov 1, 2012
KKXDrape, Surgical, AntimicrobialClass IIGeneral and plastic surgeryContract sterilizationApr 18, 2013
KMFBandage, LiquidClass IGeneral hospitalContract sterilizationMay 30, 2013
KMKDevice, Intravascular Catheter SecurementClass IGeneral hospitalContract sterilizationMay 7, 2013
KNWInstrument, BiopsyClass IIGastroenterology and urologyContract sterilizationDec 17, 2012
KOASurgical Instruments, G-U, Manual (And Accessories)Class IGastroenterology and urologyContract sterilizationMay 13, 2009
KPEContainer, I.V.Class IIGeneral hospitalContract sterilizationApr 23, 2013
KQZComponent, Traction, Non-InvasiveClass IOrthopedicContract sterilizationNov 15, 2012
KSBSet, Transfer (Blood/Plasma)Class IIHematologyContract sterilizationNov 13, 2012
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsClass IIHematologyContract sterilizationNov 13, 2012
KWQAppliance, Fixation, Spinal Intervertebral BodyClass IIOrthopedicContract sterilizationMay 13, 2013
KXGApplicator, Absorbent Tipped, SterileClass IGeneral hospitalContract sterilizationMay 2, 2013
KYWContainer, Liquid Medication, GraduatedClass IGeneral hospitalContract sterilizationNov 15, 2012
LGZWarmer, Thermal, Infusion FluidClass IIGeneral hospitalContract sterilizationFeb 28, 2018
LHCWarmer, Irrigation SolutionClass IPhysical medicineContract sterilizationApr 23, 2013
LHISet, I.V. Fluid TransferClass IIGeneral hospitalContract sterilizationApr 23, 2013
LKBPad, Alcohol, Device DisinfectantUnclassifiedGeneral hospitalContract sterilizationAug 23, 2013
LNHSystem, Nuclear Magnetic Resonance ImagingClass IIRadiologyContract sterilizationJun 29, 2016
LPZContainer, Frozen Donor Tissue StorageUnclassifiedGeneral hospitalContract sterilizationNov 30, 2012
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract sterilizationNov 1, 2012
LYASplint, Intranasal SeptalClass IEar, nose and throatContract sterilizationOct 31, 2012
LYCBone Grafting Material, SyntheticClass IIDentalContract sterilizationApr 23, 2013
LYUAccessory, Surgical ApparelClass IGeneral and plastic surgeryContract sterilizationJun 20, 2017
MAIFastener, Fixation, Biodegradable, Soft TissueClass IIOrthopedicContract sterilizationApr 19, 2013
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract sterilizationApr 25, 2013
MBIFastener, Fixation, Nondegradable, Soft TissueClass IIOrthopedicContract sterilizationOct 31, 2012
MDMInstrument, Manual, Surgical, General UseClass IGeneral and plastic surgeryContract sterilizationNov 1, 2012
MEGSyringe, AntistickClass IIGeneral hospitalContract sterilizationOct 30, 2012
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnclassifiedGeneral and plastic surgeryContract sterilizationOct 31, 2012
MHWDressing, CompressionClass IGeneral hospitalContract sterilizationOct 29, 2012
MOSCoil, Magnetic Resonance, SpecialtyClass IIRadiologyContract sterilizationMay 1, 2013
MQHMicrotools, Assisted Reproduction (Pipettes)Class IIObstetrics and gynecologyContract sterilizationOct 31, 2012
MQKLabware, Assisted ReproductionClass IIObstetrics and gynecologyContract sterilizationFeb 14, 2018
MQVFiller, Bone Void, Calcium CompoundClass IIOrthopedicContract sterilizationApr 23, 2013
MUQGlue, Surgical, ArteriesClass IIICardiovascularContract sterilizationApr 23, 2013
MUUSystem, Suction, LipoplastyClass IIGeneral and plastic surgeryContract sterilizationNov 22, 2022
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Class IICardiovascularContract sterilizationApr 23, 2013
NABGauze / Sponge,Nonresorbable For External UseClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
NACDressing, Wound, HydrophilicClass IGeneral and plastic surgeryContract sterilizationFeb 4, 2013
NADDressing, Wound, OcclusiveClass IGeneral and plastic surgeryContract sterilizationDec 19, 2012
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicClass IGeneral and plastic surgeryContract sterilizationOct 29, 2012
NAYSystem, Surgical, Computer Controlled InstrumentClass IIGastroenterology and urologyContract sterilizationApr 23, 2013
NBHAccessories, ArthroscopicClass IOrthopedicContract sterilizationOct 31, 2012
NHBPolymer, Ear, Nose And Throat, Synthetic, AbsorbableClass IIEar, nose and throatContract sterilizationOct 31, 2012
NINStent, RenalClass IIICardiovascularContract sterilizationDec 10, 2012
NIOStent, IliacClass IIICardiovascularContract sterilizationDec 10, 2012
NTBSystem, Ablation, Ultrasound And AccessoriesClass IIGeneral and plastic surgeryContract sterilizationOct 30, 2014
OAFImplant, Hearing, Active, Middle Ear, Totally ImplantedClass IIIEar, nose and throatContract sterilizationOct 29, 2012
OBJCatheter, Ultrasound, IntravascularClass IICardiovascularContract sterilizationJun 28, 2013
OCTAnti Fog Solution And Accessories, EndoscopyClass IIGastroenterology and urologyContract sterilizationOct 31, 2012
OCWEndoscopic Tissue Approximation DeviceClass IIGastroenterology and urologyContract sterilizationFeb 27, 2018
OHOFirst Aid Kit Without DrugClass IGeneral and plastic surgeryContract sterilizationDec 9, 2019
OLLSeptal Stapler/Absorbable StaplesClass IIGeneral and plastic surgeryContract sterilizationMay 1, 2013
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract sterilizationOct 16, 2024
ORGPlatelet And Plasma Separator For Bone Graft HandlingClass IIHematologyContract sterilizationNov 5, 2020
OURSacroiliac Joint FixationClass IIOrthopedicContract sterilizationOct 16, 2024
PJEBlood/Plasma Collection Device For Dna TestingClass IIClinical chemistryContract sterilizationMar 21, 2013
PJFIlluminator System For Blood ProductsClass IIIHematologyContract sterilizationJul 25, 2024
PQEOstomy Care KitClass IGastroenterology and urologyContract sterilizationFeb 14, 2018
PRJCapillary Blood Collection Device For Alternative Site CollectionClass IIClinical chemistryContract sterilizationAug 31, 2018
PUIDrape, Surgical, ExemptClass IIGeneral and plastic surgeryContract sterilizationMar 2, 2018
QAUHemostatic Device For Endoscopic Gastrointestinal UseClass IIGeneral and plastic surgeryContract sterilizationNov 5, 2020
QBPCap, Device DisinfectantClass IIGeneral hospitalContract sterilizationFeb 20, 2020
QCZMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With ApplicatorClass IIIHematologyContract sterilizationFeb 26, 2021
QJYInfusion Pump, Drug Specific, Pharmacy-FilledClass IIGeneral hospitalContract sterilizationMay 20, 2025
QPBSystem, Suction, Lipoplasty For RemovalClass IIGeneral and plastic surgeryContract sterilizationOct 31, 2012
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnclassifiedGeneral and plastic surgeryContract sterilizationOct 31, 2012
QWYMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With ApplicatorClass IIIHematologyContract sterilizationSep 26, 2024

Other contract facilities of Sotera Health LLC