Sterigenics US LLC

Contract sterilizer · West Memphis, AR

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

2009Product codes first listed, by year (tallest: 53)2026

FDA registration: 3002907620 (openFDA record; or search FDA's registration database)
FEI number: 3002907620
Registered for: FDA registration year 2026
Establishment types: Contract sterilizer
Owner or operator: Sotera Health LLC (FDA owner/operator no. 10029425)
Registered address: 1700 College Blvd., West Memphis, AR 72301
Contract listings: 383 device listings, 129 product codes, first listed Jun 15, 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
BRZ	Set, Blood Transfusion	Class II	General hospital	Contract sterilization	Oct 30, 2012
BTO	Tube, Tracheostomy (W/Wo Connector)	Class II	Anesthesiology	Contract sterilization	Dec 19, 2019
BYD	Condenser, Heat And Moisture (Artificial Nose)	Class I	Anesthesiology	Contract sterilization	Nov 15, 2012
CAE	Airway, Oropharyngeal, Anesthesiology	Class I	Anesthesiology	Contract sterilization	Nov 16, 2012
CBT	Arterial Blood Sampling Kit	Class I	Anesthesiology	Contract sterilization	Nov 15, 2012
CCX	Support, Patient Position	Class I	Anesthesiology	Contract sterilization	Nov 15, 2012
DRS	Transducer, Blood-Pressure, Extravascular	Class II	Cardiovascular	Contract sterilization	Mar 10, 2020
DZA	Drill, Dental, Intraoral	Class I	Dental	Contract sterilization	Jul 11, 2017
DZM	Needle, Dental	Class I	Dental	Contract sterilization	Nov 13, 2012
EKS	File, Pulp Canal, Endodontic	Class I	Dental	Contract sterilization	Jul 2, 2019
EZL	Catheter, Retention Type, Balloon	Class II	Gastroenterology and urology	Contract sterilization	Nov 15, 2012
FEI	Instrument, Special Lens, For Endoscope	Class I	Gastroenterology and urology	Contract sterilization	Jun 30, 2022
FHW	Device, Impotence, Mechanical/Hydraulic	Class III	Gastroenterology and urology	Contract sterilization	Nov 13, 2012
FKX	System, Peritoneal, Automatic Delivery	Class II	Gastroenterology and urology	Contract sterilization	Oct 30, 2012
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Oct 24, 2012
FMG	Stopcock, I.V. Set	Class II	General hospital	Contract sterilization	Oct 30, 2012
FMH	Container, Specimen, Sterile	Class I	Pathology	Contract sterilization	Jun 11, 2010
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract sterilization	Mar 13, 2018
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract sterilization	Oct 30, 2012
FPB	Filter, Infusion Line	Class II	General hospital	Contract sterilization	Oct 31, 2012
FPK	Tubing, Fluid Delivery	Class II	General hospital	Contract sterilization	Aug 26, 2013
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Oct 31, 2012
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Dec 27, 2017
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract sterilization	Nov 15, 2012
FZP	Clip, Implantable	Class II	General and plastic surgery	Contract sterilization	Apr 22, 2013
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
GAD	Retractor	Class I	General and plastic surgery	Contract sterilization	Nov 16, 2012
GAE	Snare, Surgical	Class I	General and plastic surgery	Contract sterilization	Jun 30, 2022
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract sterilization	Jun 30, 2022
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Jun 6, 2013
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Nov 15, 2012
GEY	Motor, Surgical Instrument, Ac-Powered	Class I	General and plastic surgery	Contract sterilization	Apr 22, 2013
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract sterilization	Oct 31, 2012
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Apr 22, 2013
HIF	Insufflator, Laparoscopic	Class II	Obstetrics and gynecology	Contract sterilization	Apr 26, 2023
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
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Class II	Ophthalmic	Contract sterilization	Mar 20, 2013
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Apr 18, 2013
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Oct 30, 2012
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract sterilization	Jun 30, 2022
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract sterilization	Oct 30, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Oct 31, 2012
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract sterilization	May 3, 2013
HWQ	Passer	Class I	Orthopedic	Contract sterilization	Jun 30, 2022
HXC	Wrench	Class I	Orthopedic	Contract sterilization	Oct 30, 2014
HXT	Tape, Orthopedic	Class I	General and plastic surgery	Contract sterilization	Aug 14, 2019
HXX	Screwdriver	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
JAK	System, X-Ray, Tomography, Computed	Class II	Radiology	Contract sterilization	Nov 15, 2012
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract sterilization	Mar 31, 2013
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	Class II	General and plastic surgery	Contract sterilization	Apr 19, 2013
JDO	Device, Fixation, Proximal Femoral, Implant	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Apr 5, 2013
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract sterilization	Nov 8, 2012
JDZ	Mixer, Cement, For Clinical Use	Class I	Orthopedic	Contract sterilization	Oct 29, 2012
JOL	Catheter And Tip, Suction	Class II	General hospital	Contract sterilization	Jun 15, 2009
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Class II	Orthopedic	Contract sterilization	Apr 12, 2013
KCY	Tourniquet, Pneumatic	Class I	General and plastic surgery	Contract sterilization	Oct 29, 2012
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Class II	Gastroenterology and urology	Contract sterilization	Oct 30, 2012
KGN	Wound Dressing With Animal-Derived Material(S)	Unclassified	General and plastic surgery	Contract sterilization	Jul 5, 2017
KIH	Dispenser, Cement	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
KIZ	Dish, Tissue Culture	Class I	Hematology	Contract sterilization	Nov 1, 2012
KKX	Drape, Surgical, Antimicrobial	Class II	General and plastic surgery	Contract sterilization	Nov 16, 2012
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract sterilization	May 7, 2013
KNM	Device, Pressure Applying	Class I	Physical medicine	Contract sterilization	Apr 25, 2023
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Class II	Gastroenterology and urology	Contract sterilization	Nov 15, 2012
KPE	Container, I.V.	Class II	General hospital	Contract sterilization	Oct 11, 2017
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Class II	Hematology	Contract sterilization	Oct 30, 2012
KTI	Bronchoscope Accessory	Class II	Ear, nose and throat	Contract sterilization	Nov 16, 2012
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract sterilization	Apr 18, 2013
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract sterilization	Apr 12, 2013
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Class II	Orthopedic	Contract sterilization	Jan 15, 2013
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Oct 30, 2012
LJH	System, Irrigation, Urological	Class II	Gastroenterology and urology	Contract sterilization	Oct 30, 2012
LKB	Pad, Alcohol, Device Disinfectant	Unclassified	General hospital	Contract sterilization	Aug 23, 2013
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract sterilization	Nov 16, 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 31, 2013
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
LRY	Punch, Surgical	Class I	General and plastic surgery	Contract sterilization	Oct 24, 2012
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
LZN	Cement Obturator	Class II	General and plastic surgery	Contract sterilization	Mar 31, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
LZU	Plug, Punctum	Unclassified	Ophthalmic	Contract sterilization	Nov 16, 2012
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Jun 30, 2022
MBB	Bone Cement, Antibiotic	Class II	Orthopedic	Contract sterilization	Jan 31, 2013
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Oct 31, 2012
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
MEB	Pump, Infusion, Elastomeric	Class II	General hospital	Contract sterilization	Oct 30, 2012
MEG	Syringe, Antistick	Class II	General hospital	Contract sterilization	Oct 30, 2012
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
MGB	Device, Hemostasis, Vascular	Class III	Cardiovascular	Contract sterilization	Oct 31, 2012
NAC	Dressing, Wound, Hydrophilic	Class I	General and plastic surgery	Contract sterilization	Feb 4, 2013
NAD	Dressing, Wound, Occlusive	Class I	General and plastic surgery	Contract sterilization	Dec 19, 2012
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
NEP	System/Device, Pharmacy Compounding	Class II	General hospital	Contract sterilization	Jul 31, 2013
NEU	Marker, Radiographic, Implantable	Class II	General and plastic surgery	Contract sterilization	Apr 22, 2013
NGT	Saline, Vascular Access Flush	Class II	General hospital	Contract sterilization	Mar 13, 2018
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
NXH	Nursing Pad, Cohesive Gel	Class I	General hospital	Contract sterilization	Apr 22, 2013
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Class III	Orthopedic	Contract sterilization	Apr 22, 2013
OCW	Endoscopic Tissue Approximation Device	Class II	Gastroenterology and urology	Contract sterilization	Jul 5, 2017
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Apr 22, 2013
OOG	Knee Arthroplasty Implantation System	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
OSN	Software For Diagnosis/Treatment	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
PEW	Implantable Transprostatic Tissue Retractor System	Class II	Gastroenterology and urology	Contract sterilization	Feb 9, 2021
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	Class III	General and plastic surgery	Contract sterilization	May 9, 2013
PNU	Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery	Class II	Obstetrics and gynecology	Contract sterilization	Apr 27, 2023

Sterigenics US LLC

Devices listed as contract work

Other contract facilities of Sotera Health LLC