Sterigenics U.S. LLC

Contract sterilizer · Hayward, CA

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

2009Product codes first listed, by year (tallest: 52)2026

FDA registration: 2953359 (openFDA record; or search FDA's registration database)
FEI number: 3000215205
Registered for: FDA registration year 2026
Establishment types: Contract sterilizer
Owner or operator: Sotera Health LLC (FDA owner/operator no. 10029425)
Registered address: 2311 Lincoln Ave, Hayward, CA 94545
Contract listings: 166 device listings, 114 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 code	Device (FDA name)	Class	Category	Role	First listed
DRA	Catheter, Steerable	Class II	Cardiovascular	Contract sterilization	Aug 12, 2014
DRE	Dilator, Vessel, For Percutaneous Catheterization	Class II	Cardiovascular	Contract sterilization	Nov 12, 2012
DWZ	Device, Biopsy, Endomyocardial	Class II	Cardiovascular	Contract sterilization	Nov 8, 2012
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Nov 12, 2012
DXX	System, Catheter Control, Steerable	Class II	Cardiovascular	Contract sterilization	Aug 12, 2014
DYB	Introducer, Catheter	Class II	Cardiovascular	Contract sterilization	Oct 24, 2012
DZJ	Driver, Wire, And Bone Drill, Manual	Class II	Dental	Contract sterilization	Feb 9, 2021
EKD	Instrument, Cutting, Operative	Class I	Dental	Contract sterilization	Nov 12, 2012
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class II	Ear, nose and throat	Contract sterilization	Jun 13, 2023
EZD	Catheter, Straight	Class II	Gastroenterology and urology	Contract sterilization	Jul 16, 2018
FJL	Resectoscope	Class II	Gastroenterology and urology	Contract sterilization	Jul 31, 2023
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Mar 20, 2013
FWP	Prosthesis, Chin, Internal	Class II	General and plastic surgery	Contract sterilization	Nov 8, 2012
FZP	Clip, Implantable	Class II	General and plastic surgery	Contract sterilization	Nov 12, 2012
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
GAA	Needle, Aspiration And Injection, Disposable	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
GAB	Needle, Suturing, Disposable	Class I	General and plastic surgery	Contract sterilization	Oct 30, 2012
GAD	Retractor	Class I	General and plastic surgery	Contract sterilization	Nov 16, 2012
GDF	Guide, Needle, Surgical	Class I	General and plastic surgery	Contract sterilization	Mar 20, 2013
GDM	Needle, Aspiration And Injection, Reusable	Class I	General and plastic surgery	Contract sterilization	Mar 30, 2014
GDW	Staple, Implantable	Class II	General and plastic surgery	Contract sterilization	Jan 23, 2014
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
GEH	Unit, Cryosurgical, Accessories	Class II	General and plastic surgery	Contract sterilization	Mar 20, 2013
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Nov 12, 2012
GEN	Forceps, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Apr 12, 2013
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract sterilization	Oct 31, 2012
GFI	Osteotome, Manual	Class I	General and plastic surgery	Contract sterilization	Mar 22, 2018
GWM	Device, Monitoring, Intracranial Pressure	Class II	Neurology	Contract sterilization	Mar 22, 2018
GXP	Methyl Methacrylate For Cranioplasty	Class II	Neurology	Contract sterilization	Nov 8, 2012
GXZ	Electrode, Needle	Class II	Neurology	Contract sterilization	Nov 12, 2012
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract sterilization	Jun 13, 2023
HCF	Instrument, Ligature Passing And Knot Tying	Class I	General and plastic surgery	Contract sterilization	Feb 7, 2014
HDQ	Dilator, Cervical, Fixed Size	Class I	Obstetrics and gynecology	Contract sterilization	Jul 27, 2018
HHI	System, Abortion, Vacuum	Class II	Obstetrics and gynecology	Contract sterilization	Nov 12, 2012
HHK	Curette, Suction, Endometrial (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Nov 7, 2012
HIG	Insufflator, Hysteroscopic	Class II	Obstetrics and gynecology	Contract sterilization	Apr 25, 2023
HIH	Hysteroscope (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Apr 25, 2023
HKP	Instrument, Vitreous Aspiration And Cutting, Battery-Powered	Class II	Ophthalmic	Contract sterilization	Mar 20, 2013
HMX	Cannula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Mar 20, 2013
HMZ	Trabeculotome	Class I	Ophthalmic	Contract sterilization	Feb 6, 2014
HNR	Forceps, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNS	Expressor	Class I	Ophthalmic	Contract sterilization	Jul 31, 2023
HNZ	Curette, Ophthalmic	Class I	Ophthalmic	Contract sterilization	May 2, 2013
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Class II	Ophthalmic	Contract sterilization	Nov 12, 2012
HQL	Intraocular Lens	Class III	Ophthalmic	Contract sterilization	Jan 2, 2015
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 12, 2012
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Oct 30, 2012
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract sterilization	Nov 12, 2012
HTD	Forceps	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract sterilization	Feb 9, 2021
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
HWA	Impactor	Class I	Orthopedic	Contract sterilization	Nov 12, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 12, 2012
HWJ	Awl	Class I	Orthopedic	Contract sterilization	Jun 13, 2023
HWM	Osteotome	Class I	General and plastic surgery	Contract sterilization	Mar 22, 2018
HWQ	Passer	Class I	Orthopedic	Contract sterilization	Dec 4, 2012
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract sterilization	Feb 21, 2024
HWT	Template	Class I	Orthopedic	Contract sterilization	Jul 17, 2013
IKD	Cable, Electrode	Class II	Physical medicine	Contract sterilization	Nov 12, 2012
IKT	Electrode, Needle, Diagnostic Electromyograph	Class II	Physical medicine	Contract sterilization	Nov 12, 2012
JAD	System, Therapeutic, X-Ray	Class II	Radiology	Contract sterilization	Nov 12, 2012
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract sterilization	Mar 20, 2013
JXG	Shunt, Central Nervous System And Components	Class II	Neurology	Contract sterilization	Mar 22, 2018
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract sterilization	May 13, 2009
KIH	Dispenser, Cement	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Class II	Obstetrics and gynecology	Contract sterilization	Nov 7, 2012
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract sterilization	Nov 12, 2012
KQT	Evacuator, Gastro-Urology	Class II	Gastroenterology and urology	Contract sterilization	Jul 31, 2023
KRD	Device, Vascular, For Promoting Embolization	Class II	Cardiovascular	Contract sterilization	Aug 8, 2025
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Class II	Hematology	Contract sterilization	Jan 26, 2013
KXK	Source, Brachytherapy, Radionuclide	Class II	Radiology	Contract sterilization	Nov 12, 2012
KYD	Strip, Schirmer	Class I	Ophthalmic	Contract sterilization	Nov 12, 2012
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Jun 13, 2023
LJH	System, Irrigation, Urological	Class II	Gastroenterology and urology	Contract sterilization	Oct 30, 2012
LMF	Agent, Absorbable Hemostatic, Collagen Based	Class III	General and plastic surgery	Contract sterilization	May 9, 2013
LOD	Bone Cement	Class II	Orthopedic	Contract sterilization	Jan 30, 2014
LRC	Instrument, Ent Manual Surgical	Class I	Ear, nose and throat	Contract sterilization	Nov 14, 2012
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
LXZ	Guard, Instrument	Class I	General and plastic surgery	Contract sterilization	Jul 31, 2023
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract sterilization	Nov 12, 2012
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
MGB	Device, Hemostasis, Vascular	Class III	Cardiovascular	Contract sterilization	Jan 30, 2014
MJG	Device, Percutaneous, Biopsy	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
MLZ	Vitrectomy, Instrument Cutter	Class II	Ophthalmic	Contract sterilization	Jul 31, 2023
MNB	Device, Thermal Ablation, Endometrial	Class III	Obstetrics and gynecology	Contract sterilization	Aug 31, 2016
MPA	Endoilluminator	Class II	Gastroenterology and urology	Contract sterilization	Mar 20, 2013
MQK	Labware, Assisted Reproduction	Class II	Obstetrics and gynecology	Contract sterilization	Nov 12, 2012
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract sterilization	Oct 30, 2012
MRH	Pump, Infusion, Ophthalmic	Class II	General hospital	Contract sterilization	Feb 6, 2014
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract sterilization	Nov 1, 2012
MTJ	Wax, Bone	Unclassified	Orthopedic	Contract sterilization	Nov 8, 2012
MUU	System, Suction, Lipoplasty	Class II	General and plastic surgery	Contract sterilization	Jul 5, 2017
MWS	Stabilizer, Heart	Class I	Cardiovascular	Contract sterilization	Nov 12, 2012
NAD	Dressing, Wound, Occlusive	Class I	General and plastic surgery	Contract sterilization	Sep 11, 2018
NBE	Sealant, Polymerizing	Class III	General and plastic surgery	Contract sterilization	Nov 12, 2012
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
NBW	System, Test, Blood Glucose, Over The Counter	Class II	Clinical chemistry	Contract sterilization	Dec 2, 2019
NDN	Cement, Bone, Vertebroplasty	Class II	Orthopedic	Contract sterilization	Jan 30, 2014
NEP	System/Device, Pharmacy Compounding	Class II	General hospital	Contract sterilization	Jun 13, 2023
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Class II	Ear, nose and throat	Contract sterilization	Jul 5, 2017
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract sterilization	Dec 2, 2019
NQO	Prosthesis, Spinous Process Spacer/Plate	Class III	Orthopedic	Contract sterilization	Nov 1, 2012
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Class I	Orthopedic	Contract sterilization	Dec 17, 2012
OCJ	Spinal Channeling Instrument, Vertebroplasty	Class I	Orthopedic	Contract sterilization	Nov 12, 2012
OCW	Endoscopic Tissue Approximation Device	Class II	Gastroenterology and urology	Contract sterilization	Jul 27, 2018
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract sterilization	Jul 5, 2017
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	Class II	General and plastic surgery	Contract sterilization	Mar 19, 2013
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Aug 8, 2025
PEW	Implantable Transprostatic Tissue Retractor System	Class II	Gastroenterology and urology	Contract sterilization	Jan 30, 2014
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	Class II	General and plastic surgery	Contract sterilization	Feb 2, 2016
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	Class III	General and plastic surgery	Contract sterilization	May 9, 2013
PNL	Magnetic Surgical System	Class II	General and plastic surgery	Contract sterilization	Jul 5, 2017
PQN	Carbon Dioxide Gas Controlled Tissue Expander	Class II	General and plastic surgery	Contract sterilization	Jun 26, 2017
QVV	Medial Knee Implanted Shock Absorber	Class II	Orthopedic	Contract sterilization	Sep 9, 2024

Sterigenics U.S. LLC

Devices listed as contract work

Other contract facilities of Sotera Health LLC