Sterigenics U.S., LLC

Contract sterilizer · Atlanta, GA

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

FDA registration: 1018470 (openFDA record; or search FDA's registration database)
FEI number: 1018470
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: 2971 Olympic Industrial Dr SE Ste 116, Atlanta, GA 30339
Contract listings: 373 device listings, 187 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
BRZ	Set, Blood Transfusion	Class II	General hospital	Contract sterilization	Dec 21, 2016
BSO	Catheter, Conduction, Anesthetic	Class II	Anesthesiology	Contract sterilization	Dec 20, 2016
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Class II	Anesthesiology	Contract sterilization	Nov 28, 2012
BYY	Tube, Aspirating, Flexible, Connecting	Class II	General hospital	Contract sterilization	Nov 1, 2012
BZA	Connector, Airway (Extension)	Class I	Anesthesiology	Contract sterilization	Apr 30, 2013
CAZ	Anesthesia Conduction Kit	Class II	Anesthesiology	Contract sterilization	Aug 23, 2013
DQO	Catheter, Intravascular, Diagnostic	Class II	Cardiovascular	Contract sterilization	Apr 29, 2013
DQX	Wire, Guide, Catheter	Class II	Cardiovascular	Contract sterilization	Jul 21, 2017
DQY	Catheter, Percutaneous	Class II	Cardiovascular	Contract sterilization	Mar 8, 2017
DRC	Trocar	Class II	Cardiovascular	Contract sterilization	Nov 13, 2012
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Nov 13, 2012
DXT	Injector And Syringe, Angiographic	Class II	Cardiovascular	Contract sterilization	Apr 29, 2013
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Class II	Cardiovascular	Contract sterilization	Nov 29, 2012
DYB	Introducer, Catheter	Class II	Cardiovascular	Contract sterilization	Dec 20, 2016
EBG	Crown And Bridge, Temporary, Resin	Class II	Dental	Contract sterilization	Mar 8, 2017
EIA	Unit, Operative Dental	Class I	Dental	Contract sterilization	Mar 8, 2017
EIC	Syringe, Periodontic, Endodontic, Irrigating	Class I	Dental	Contract sterilization	Apr 26, 2017
EMF	Knife, Surgical	Class I	General and plastic surgery	Contract sterilization	Jul 31, 2013
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class II	Ear, nose and throat	Contract sterilization	Apr 29, 2013
FBQ	Trocar, Gastro-Urology	Class II	Gastroenterology and urology	Contract sterilization	Feb 27, 2018
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class II	Gastroenterology and urology	Contract sterilization	Aug 17, 2021
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Dec 21, 2016
FMG	Stopcock, I.V. Set	Class II	General hospital	Contract sterilization	Feb 26, 2013
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract sterilization	Mar 8, 2017
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class II	General hospital	Contract sterilization	Dec 12, 2024
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract sterilization	Nov 13, 2012
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Dec 10, 2012
FRN	Pump, Infusion	Class II	General hospital	Contract sterilization	Dec 21, 2016
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Mar 9, 2018
FRZ	Device, Patient Transfer, Powered	Class II	General hospital	Contract sterilization	Dec 21, 2016
FSZ	Light, Surgical, Carrier	Class II	General and plastic surgery	Contract sterilization	Nov 14, 2012
FTA	Light, Surgical, Accessories	Class II	General and plastic surgery	Contract sterilization	Nov 15, 2012
FTL	Mesh, Surgical, Polymeric	Class II	General and plastic surgery	Contract sterilization	Nov 13, 2012
FTM	Mesh, Surgical	Class II	General and plastic surgery	Contract sterilization	Nov 14, 2012
FWP	Prosthesis, Chin, Internal	Class II	General and plastic surgery	Contract sterilization	Nov 14, 2012
FWZ	Operating Room Accessories Table Tray	Class I	General and plastic surgery	Contract sterilization	Oct 29, 2012
FYA	Gown, Surgical	Class II	General and plastic surgery	Contract sterilization	Dec 4, 2012
FYC	Gown, Isolation, Surgical	Class II	General and plastic surgery	Contract sterilization	Mar 8, 2017
FZP	Clip, Implantable	Class II	General and plastic surgery	Contract sterilization	Jun 6, 2013
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
GAC	Rasp, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Oct 31, 2012
GAD	Retractor	Class I	General and plastic surgery	Contract sterilization	Nov 14, 2012
GAG	Stapler, Surgical	Class II	General hospital	Contract sterilization	Jul 26, 2013
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class II	General and plastic surgery	Contract sterilization	Dec 21, 2016
GAP	Suture, Nonabsorbable, Silk	Class II	General and plastic surgery	Contract sterilization	Jun 6, 2013
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class II	General and plastic surgery	Contract sterilization	Jun 6, 2013
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	Class II	General and plastic surgery	Contract sterilization	Jun 6, 2013
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract sterilization	Dec 13, 2012
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	Class II	General and plastic surgery	Contract sterilization	Jun 6, 2013
GAZ	Tubing, Noninvasive	Class II	General hospital	Contract sterilization	Nov 1, 2012
GBW	Catheter, Peritoneal	Class I	General and plastic surgery	Contract sterilization	Apr 29, 2013
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract sterilization	Oct 29, 2012
GCB	Needle, Catheter	Class I	General and plastic surgery	Contract sterilization	Dec 17, 2012
GCI	Laryngoscope, Endoscope	Class II	Gastroenterology and urology	Contract sterilization	Feb 27, 2018
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Nov 13, 2012
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	Class II	General hospital	Contract sterilization	Feb 4, 2013
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	Class I	General and plastic surgery	Contract sterilization	Nov 14, 2012
GDH	Gouge, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Feb 27, 2018
GDT	Staple, Removable (Skin)	Class I	General and plastic surgery	Contract sterilization	Jul 31, 2013
GDW	Staple, Implantable	Class II	General and plastic surgery	Contract sterilization	Feb 27, 2018
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Oct 30, 2012
GET	Motor, Surgical Instrument, Pneumatic Powered	Class I	General and plastic surgery	Contract sterilization	Feb 27, 2018
GEX	Powered Laser Surgical Instrument	Class II	General and plastic surgery	Contract sterilization	Nov 13, 2012
GXZ	Electrode, Needle	Class II	Neurology	Contract sterilization	Apr 29, 2013
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Apr 29, 2013
HBO	Clip, Scalp	Class II	Neurology	Contract sterilization	Apr 11, 2013
HET	Laparoscope, Gynecologic (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	May 1, 2013
HFX	Clamp, Circumcision	Class II	Obstetrics and gynecology	Contract sterilization	Feb 26, 2018
HIB	Speculum, Vaginal, Nonmetal	Class II	Obstetrics and gynecology	Contract sterilization	Jul 25, 2024
HMX	Cannula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Apr 29, 2013
HNW	Dilator, Lachrymal	Class I	Ophthalmic	Contract sterilization	Apr 29, 2013
HPZ	Implant, Eye Sphere	Class II	Ophthalmic	Contract sterilization	Nov 14, 2012
HQB	Photocoagulator And Accessories	Class II	Ophthalmic	Contract sterilization	Aug 6, 2015
HQF	Laser, Ophthalmic	Class II	Ophthalmic	Contract sterilization	Nov 13, 2012
HQN	Conformer, Ophthalmic	Class II	Ophthalmic	Contract sterilization	Nov 14, 2012
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	Class I	General and plastic surgery	Contract sterilization	Nov 13, 2012
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Nov 13, 2012
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Oct 25, 2019
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract sterilization	Apr 29, 2013
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 13, 2012
IKD	Cable, Electrode	Class II	Physical medicine	Contract sterilization	Nov 12, 2012
IQF	Orthosis, Cervical-Thoracic, Rigid	Class I	Physical medicine	Contract sterilization	Dec 21, 2016
ITX	Transducer, Ultrasonic, Diagnostic	Class II	Radiology	Contract sterilization	Nov 13, 2012
IZI	System, X-Ray, Angiographic	Class II	Radiology	Contract sterilization	Nov 13, 2012
IZQ	Injector, Contrast Medium, Automatic	Class II	Cardiovascular	Contract sterilization	Jul 7, 2025
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Class II	Radiology	Contract sterilization	Oct 24, 2012
JCY	Catheter, Infusion	Class I	General and plastic surgery	Contract sterilization	Dec 20, 2016
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Apr 29, 2013
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract sterilization	Apr 19, 2013
JOS	Electrode, Electrosurgical	Class II	General and plastic surgery	Contract sterilization	Apr 29, 2013
JOW	Sleeve, Limb, Compressible	Class II	Cardiovascular	Contract sterilization	Dec 10, 2012
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Nov 13, 2012
KCY	Tourniquet, Pneumatic	Class I	General and plastic surgery	Contract sterilization	Oct 29, 2012
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract sterilization	May 13, 2009
KGO	Surgeon'S Gloves	Class I	General and plastic surgery	Contract sterilization	Nov 30, 2012
KGX	Tape And Bandage, Adhesive	Class I	General hospital	Contract sterilization	Nov 12, 2012
KGZ	Accessories, Catheter	Class I	General and plastic surgery	Contract sterilization	Dec 20, 2016
KKX	Drape, Surgical, Antimicrobial	Class II	General and plastic surgery	Contract sterilization	Nov 13, 2012
KMF	Bandage, Liquid	Class I	General hospital	Contract sterilization	Mar 9, 2018
KMI	Monitor, Bed Patient	Class I	General hospital	Contract sterilization	Dec 21, 2016
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract sterilization	May 7, 2013
KOC	Accessories, Blood Circuit, Hemodialysis	Class II	Gastroenterology and urology	Contract sterilization	Aug 17, 2021
KOE	Dilator, Urethral	Class II	Gastroenterology and urology	Contract sterilization	Apr 29, 2013
KPE	Container, I.V.	Class II	General hospital	Contract sterilization	Nov 13, 2012
KQM	Camera, Surgical And Accessories	Class I	General and plastic surgery	Contract sterilization	Apr 26, 2017
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
KSB	Set, Transfer (Blood/Plasma)	Class II	Hematology	Contract sterilization	Nov 13, 2012
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Class II	Hematology	Contract sterilization	Nov 13, 2012
KTI	Bronchoscope Accessory	Class II	Ear, nose and throat	Contract sterilization	Dec 20, 2016
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
KWH	Prosthesis, Toe, Constrained, Polymer	Class II	Orthopedic	Contract sterilization	Jun 2, 2026
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract sterilization	Oct 25, 2019
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
KYX	Dispenser, Liquid Medication	Class I	General hospital	Contract sterilization	Dec 21, 2016
KZD	Infusor, Pressure, For I.V. Bags	Class I	General hospital	Contract sterilization	Dec 10, 2012
LDE	Stethoscope, Manual	Class I	Cardiovascular	Contract sterilization	Dec 21, 2016
LDF	Electrode, Pacemaker, Temporary	Class II	Cardiovascular	Contract sterilization	Feb 27, 2018
LDR	Controller, Infusion, Intravascular, Electronic	Class II	General hospital	Contract sterilization	Apr 29, 2013
LFL	Instrument, Ultrasonic Surgical	Unclassified	General and plastic surgery	Contract sterilization	Feb 19, 2019
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Nov 13, 2012
LJH	System, Irrigation, Urological	Class II	Gastroenterology and urology	Contract sterilization	Dec 21, 2016
LKF	Cannula, Manipulator/Injector, Uterine	Class II	Obstetrics and gynecology	Contract sterilization	Nov 13, 2012
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
LRC	Instrument, Ent Manual Surgical	Class I	Ear, nose and throat	Contract sterilization	Dec 20, 2016
LRO	General Surgery Tray	Class II	General and plastic surgery	Contract sterilization	Mar 8, 2017
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract sterilization	Nov 30, 2012
LTI	Implant, Intragastric For Morbid Obesity	Class III	Gastroenterology and urology	Contract sterilization	Mar 8, 2017
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
LYA	Splint, Intranasal Septal	Class I	Ear, nose and throat	Contract sterilization	Nov 14, 2012
LZN	Cement Obturator	Class II	General and plastic surgery	Contract sterilization	Apr 22, 2013
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract sterilization	Jul 3, 2017
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Apr 29, 2013
MAV	Syringe, Balloon Inflation	Class II	Cardiovascular	Contract sterilization	Apr 29, 2013
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Nov 13, 2012
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract sterilization	Apr 22, 2013
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
MIB	Elastomer, Silicone Block	Class II	Ear, nose and throat	Contract sterilization	Nov 13, 2012
MLS	Labor And Delivery Kit	Class II	Obstetrics and gynecology	Contract sterilization	Apr 26, 2017
MMP	Cover, Barrier, Protective	Class II	General and plastic surgery	Contract sterilization	Mar 8, 2017
MNF	Implant, Temporal	Class II	General and plastic surgery	Contract sterilization	Nov 14, 2012
MNU	Staple, Absorbable	Class II	Orthopedic	Contract sterilization	Apr 29, 2013
MQF	Catheter, Assisted Reproduction	Class II	Obstetrics and gynecology	Contract sterilization	Nov 13, 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	Nov 13, 2012
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
NEW	Suture, Surgical, Absorbable, Polydioxanone	Class II	General and plastic surgery	Contract sterilization	Dec 21, 2016
NFM	Expander, Tissue, Orbital	Class II	Ophthalmic	Contract sterilization	Nov 13, 2012
NLF	Oximeter, Reprocessed	Class II	Cardiovascular	Contract sterilization	Dec 10, 2012
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Class II	Gastroenterology and urology	Contract sterilization	Dec 10, 2012
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unclassified	General and plastic surgery	Contract sterilization	Dec 10, 2012
NLU	Forceps, Biopsy, Electric, Reprocessed	Class II	Gastroenterology and urology	Contract sterilization	Dec 10, 2012
NMD	Oximeter, Tissue Saturation, Reprocessed	Class II	Cardiovascular	Contract sterilization	Dec 21, 2016
NNI	Container, Specimen, Non-Sterile	Class I	Pathology	Contract sterilization	Nov 13, 2012
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
NPK	Barrier, Synthetic, Intraoral	Class II	Dental	Contract sterilization	Nov 14, 2012
NPP	Reprocessed Blood Pressure Cuff	Class II	Cardiovascular	Contract sterilization	Dec 21, 2016
NRU	Chair, Dental, Without Operative Unit	Class I	Dental	Contract sterilization	Apr 26, 2017
NTB	System, Ablation, Ultrasound And Accessories	Class II	General and plastic surgery	Contract sterilization	Oct 30, 2014
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	Class II	General and plastic surgery	Contract sterilization	Dec 10, 2012
OCT	Anti Fog Solution And Accessories, Endoscopy	Class II	Gastroenterology and urology	Contract sterilization	Feb 27, 2018
OCW	Endoscopic Tissue Approximation Device	Class II	Gastroenterology and urology	Contract sterilization	Feb 27, 2018
OEQ	Angiography/Angioplasty Kit	Class II	Cardiovascular	Contract sterilization	Apr 26, 2017
OES	Cardiac Catheterization Kit	Class II	Cardiovascular	Contract sterilization	Apr 26, 2017
OEW	Tracking, Soft Tissue, Intraoperative	Class II	Neurology	Contract sterilization	Feb 26, 2018
OFL	Percutaneous Sheath Introducer Kit	Class II	Cardiovascular	Contract sterilization	Dec 13, 2024
OFT	Spinal Epidural Anesthesia Kit	Class II	Anesthesiology	Contract sterilization	Aug 23, 2013
OFU	Spinal Anesthesia Kit	Class II	Anesthesiology	Contract sterilization	Aug 23, 2013
OGD	Custom Anesthesia Tray	Class II	Anesthesiology	Contract sterilization	Jul 30, 2019
OGE	Epidural Anesthesia Kit	Class II	Anesthesiology	Contract sterilization	Jul 30, 2019
OGJ	Nerve Block Tray	Class II	Anesthesiology	Contract sterilization	Apr 26, 2017
OHM	Cesarean Section Tray	Class II	Obstetrics and gynecology	Contract sterilization	Apr 26, 2017
OKS	Lacrimal Stents And Intubation Sets	Unclassified	Ophthalmic	Contract sterilization	Nov 14, 2012
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract sterilization	Apr 11, 2024
OSN	Software For Diagnosis/Treatment	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
OVN	Suture Kit	Class II	General and plastic surgery	Contract sterilization	Aug 23, 2013
PCF	Sampler, Endocervical	Class II	Obstetrics and gynecology	Contract sterilization	Dec 21, 2016
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract sterilization	Apr 11, 2024
PUI	Drape, Surgical, Exempt	Class II	General and plastic surgery	Contract sterilization	Mar 2, 2018
PWY	Lumbar Puncture Tray (Adult & Pediatric)	Class II	General hospital	Contract sterilization	Jun 26, 2024
QEH	Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact	Class II	General hospital	Contract sterilization	Dec 12, 2024
SEL	Securement Wound Dressing For Reduction Of Infection	Unclassified	General and plastic surgery	Contract sterilization	Apr 11, 2024

Sterigenics U.S., LLC

Devices listed as contract work

Other contract facilities of Sotera Health LLC