Sterigenics Radiation Technologies, LLC

Contract manufacturer and sterilizer · San Diego, CA

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

2012Product codes first listed, by year (tallest: 41)2026

FDA registration: 2024024 (openFDA record; or search FDA's registration database)
FEI number: 2024024
Registered for: FDA registration year 2026
Establishment types: Manufacturer for export only; Contract manufacturer; Contract sterilizer
Owner or operator: Sotera Health LLC (FDA owner/operator no. 10029425)
Registered address: 7695 Formula Pl, San Diego, CA 92121
Contract listings: 165 device listings, 93 product codes, first listed Oct 24, 2012
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
BZO	Set, Tubing And Support, Ventilator (W Harness)	Class I	Anesthesiology	Contract sterilization	Nov 30, 2012
DQO	Catheter, Intravascular, Diagnostic	Class II	Cardiovascular	Contract sterilization	Oct 25, 2019
DQX	Wire, Guide, Catheter	Class II	Cardiovascular	Contract sterilization	Mar 21, 2013
DQY	Catheter, Percutaneous	Class II	Cardiovascular	Contract sterilization	Mar 21, 2013
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Class II	Cardiovascular	Contract sterilization	Nov 27, 2012
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Class II	Cardiovascular	Contract sterilization	Mar 22, 2013
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Nov 12, 2012
DXY	Implantable Pacemaker Pulse-Generator	Class III	Cardiovascular	Contract sterilization	Nov 29, 2012
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Class II	Cardiovascular	Contract sterilization	Nov 29, 2012
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract sterilization	Nov 30, 2012
EZD	Catheter, Straight	Class II	Gastroenterology and urology	Contract sterilization	Oct 24, 2019
EZX	Mesh, Surgical, Metal	Class II	General and plastic surgery	Contract sterilization	Nov 29, 2012
FGE	Stents, Drains And Dilators For The Biliary Ducts	Class II	Gastroenterology and urology	Contract sterilization	Mar 21, 2013
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class II	Gastroenterology and urology	Contract sterilization	Oct 25, 2019
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Mar 22, 2018
FMG	Stopcock, I.V. Set	Class II	General hospital	Contract sterilization	Nov 30, 2012
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract sterilization	Mar 15, 2018
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class II	General hospital	Contract sterilization	Nov 30, 2012
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract sterilization	Oct 24, 2019
FPK	Tubing, Fluid Delivery	Class II	General hospital	Contract sterilization	Oct 25, 2019
FRL	Fiber, Medical, Absorbent	Class I	General hospital	Contract sterilization	Nov 15, 2012
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Nov 18, 2019
FTL	Mesh, Surgical, Polymeric	Class II	General and plastic surgery	Contract sterilization	Nov 29, 2012
FTM	Mesh, Surgical	Class II	General and plastic surgery	Contract sterilization	Nov 29, 2012
FZP	Clip, Implantable	Class II	General and plastic surgery	Contract sterilization	Mar 21, 2023
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Oct 21, 2024
GWM	Device, Monitoring, Intracranial Pressure	Class II	Neurology	Contract sterilization	Feb 9, 2021
GXR	Cover, Burr Hole	Class II	Neurology	Contract sterilization	Feb 25, 2013
GXY	Electrode, Cutaneous	Class II	Neurology	Contract sterilization	Nov 30, 2012
GXZ	Electrode, Needle	Class II	Neurology	Contract sterilization	Nov 30, 2012
HBW	Fastener, Plate, Cranioplasty	Class II	Neurology	Contract sterilization	Feb 25, 2013
HNN	Knife, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 29, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 29, 2012
ITX	Transducer, Ultrasonic, Diagnostic	Class II	Radiology	Contract sterilization	Jul 13, 2020
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Class II	Radiology	Contract sterilization	Jul 13, 2020
JEY	Plate, Bone	Class II	Dental	Contract sterilization	Feb 25, 2013
JRC	Micro Pipette	Class I	Clinical chemistry	Contract sterilization	Nov 30, 2012
JXG	Shunt, Central Nervous System And Components	Class II	Neurology	Contract sterilization	Feb 9, 2021
KGN	Wound Dressing With Animal-Derived Material(S)	Unclassified	General and plastic surgery	Contract sterilization	Nov 29, 2012
KGX	Tape And Bandage, Adhesive	Class I	General hospital	Contract sterilization	Nov 12, 2012
KIH	Dispenser, Cement	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
KJJ	Cleanser, Root Canal	Unclassified	Dental	Contract sterilization	Nov 29, 2012
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	Class II	General and plastic surgery	Contract sterilization	Nov 30, 2012
KNT	Tubes, Gastrointestinal (And Accessories)	Class II	Gastroenterology and urology	Contract sterilization	Oct 25, 2019
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract sterilization	Nov 29, 2012
LHI	Set, I.V. Fluid Transfer	Class II	General hospital	Contract sterilization	Oct 25, 2019
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Class II	Cardiovascular	Contract sterilization	May 7, 2013
LMF	Agent, Absorbable Hemostatic, Collagen Based	Class III	General and plastic surgery	Contract sterilization	Nov 30, 2012
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Class III	Cardiovascular	Contract sterilization	Nov 29, 2012
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
LYC	Bone Grafting Material, Synthetic	Class II	Dental	Contract sterilization	Oct 24, 2012
MAF	Stent, Coronary	Class III	Cardiovascular	Contract sterilization	Mar 25, 2013
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Nov 29, 2012
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Class II	Orthopedic	Contract manufacturing	Jul 30, 2020
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Class II	Orthopedic	Contract sterilization	Nov 30, 2012
MDS	Sensor, Glucose, Invasive	Class III	Clinical chemistry	Contract sterilization	Nov 29, 2012
MKY	System, Skin Closure	Class I	General and plastic surgery	Contract sterilization	Dec 6, 2019
MOE	Collagen Corneal Shield	Class I	Ophthalmic	Contract sterilization	Nov 30, 2012
MQN	External Mandibular Fixator And/Or Distractor	Class II	Dental	Contract sterilization	Feb 25, 2013
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract sterilization	Nov 30, 2012
MSS	Folders And Injectors, Intraocular Lens (Iol)	Class I	Ophthalmic	Contract sterilization	Nov 29, 2012
MTJ	Wax, Bone	Unclassified	Orthopedic	Contract sterilization	Nov 30, 2012
MUU	System, Suction, Lipoplasty	Class II	General and plastic surgery	Contract sterilization	Oct 22, 2024
NAC	Dressing, Wound, Hydrophilic	Class I	General and plastic surgery	Contract sterilization	Feb 4, 2013
NDP	Accessories, Implant, Dental, Endosseous	Class I	Dental	Contract sterilization	Nov 9, 2012
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	Contract sterilization	Jun 29, 2015
NIM	Stent, Carotid	Class III	Cardiovascular	Contract sterilization	Mar 21, 2013
NIN	Stent, Renal	Class III	Cardiovascular	Contract sterilization	Mar 22, 2013
NIO	Stent, Iliac	Class III	Cardiovascular	Contract sterilization	Mar 22, 2013
NIQ	Coronary Drug-Eluting Stent	Class III	Cardiovascular	Contract sterilization	Jan 13, 2013
NPK	Barrier, Synthetic, Intraoral	Class II	Dental	Contract sterilization	Nov 29, 2012
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered	HDE	Cardiovascular	Contract sterilization	Jan 27, 2023
NQA	Biologic Material, Dental	Class III	Dental	Contract sterilization	Nov 29, 2012
NTE	Temporary Carotid Catheter For Embolic Capture	Class II	Cardiovascular	Contract sterilization	Mar 21, 2013
NUN	Bone Grafting Material, Human Source	Class II	Dental	Contract manufacturing	Jul 30, 2020
NUN	Bone Grafting Material, Human Source	Class II	Dental	Contract sterilization	Nov 30, 2012
NVZ	Pulse Generator, Permanent, Implantable	Class III	Cardiovascular	Contract sterilization	Nov 29, 2012
NXW	Scaffold, Infrapopliteal, Absorbable	Class III	Cardiovascular	Contract sterilization	Oct 24, 2024
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Class III	Cardiovascular	Contract sterilization	Oct 7, 2015
OMH	Pericardial Patch To Facilitate Revision Surgeries	Class II	Cardiovascular	Contract sterilization	Nov 29, 2012
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	Class II	General hospital	Contract sterilization	Oct 25, 2019
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	Class II	General and plastic surgery	Contract sterilization	Oct 22, 2024
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	Class II	General and plastic surgery	Contract sterilization	Oct 22, 2024
PIJ	Collagen Surgical Mesh Containing Drugs	Class II	General and plastic surgery	Contract sterilization	Jul 7, 2026
PNW	Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant	Class III	Orthopedic	Contract sterilization	Oct 11, 2017
PNY	Absorbable Coronary Drug-Eluting Stent	Class III	Cardiovascular	Contract sterilization	Jul 7, 2016
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	Class I	General hospital	Contract sterilization	Mar 21, 2018
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Class II	Clinical chemistry	Contract sterilization	May 18, 2021
QDK	Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management	Class II	Clinical chemistry	Contract sterilization	Sep 4, 2019
QDL	Integrated Continuous Glucose Monitoring System For Professional Retrospective Use	Class II	Clinical chemistry	Contract sterilization	May 18, 2021
QFG	Alternate Controller Enabled Insulin Infusion Pump	Class II	Clinical chemistry	Contract sterilization	Jul 7, 2026
QII	Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use	Class II	Clinical chemistry	Contract sterilization	May 18, 2021
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Class III	Cardiovascular	Contract sterilization	Feb 9, 2024
SFU	Glucose Range Monitoring System	Class II	Clinical chemistry	Contract sterilization	Jul 7, 2026

Sterigenics Radiation Technologies, LLC

Devices listed as contract work

Other contract facilities of Sotera Health LLC