Sterigenics U.S. LLC

Contract sterilizer · Mulberry, FL

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

FDA registration: 1054811 (openFDA record; or search FDA's registration database)
FEI number: 1000114185
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: 502 Prairie Mine Rd, Mulberry, FL 33860
Contract listings: 199 device listings, 124 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
BSY	Catheters, Suction, Tracheobronchial	Class I	Anesthesiology	Contract sterilization	Nov 19, 2012
BTQ	Airway, Nasopharyngeal	Class I	Anesthesiology	Contract sterilization	Nov 20, 2012
BYY	Tube, Aspirating, Flexible, Connecting	Class II	General hospital	Contract sterilization	Nov 1, 2012
DQX	Wire, Guide, Catheter	Class II	Cardiovascular	Contract sterilization	Jun 14, 2012
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Class II	Cardiovascular	Contract sterilization	Jun 14, 2012
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract sterilization	Jul 3, 2024
DXO	Transducer, Pressure, Catheter Tip	Class II	Cardiovascular	Contract sterilization	Jun 14, 2012
DZA	Drill, Dental, Intraoral	Class I	Dental	Contract sterilization	Jul 11, 2017
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract sterilization	Nov 25, 2014
ENW	Catheter, Nasopharyngeal	Class I	Ear, nose and throat	Contract sterilization	Jul 11, 2017
FAS	Electrode, Electrosurgical, Active, Urological	Class II	Gastroenterology and urology	Contract sterilization	Nov 25, 2014
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Nov 25, 2014
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Oct 31, 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
GAL	Suture, Absorbable, Natural	Class II	General and plastic surgery	Contract sterilization	Nov 25, 2014
GAP	Suture, Nonabsorbable, Silk	Class II	General and plastic surgery	Contract sterilization	Nov 25, 2014
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class II	General and plastic surgery	Contract sterilization	Jul 11, 2017
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	Class II	General and plastic surgery	Contract sterilization	Nov 25, 2014
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract sterilization	Nov 25, 2014
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Nov 25, 2014
GCZ	Retainer, Surgical	Class I	General and plastic surgery	Contract sterilization	Nov 30, 2012
GDF	Guide, Needle, Surgical	Class I	General and plastic surgery	Contract sterilization	Mar 20, 2013
GDX	Scalpel, One-Piece	Class I	General and plastic surgery	Contract sterilization	Nov 30, 2012
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
GEC	Brush, Scrub, Operating-Room	Class I	General and plastic surgery	Contract sterilization	May 14, 2013
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Nov 25, 2014
GES	Blade, Scalpel	Class I	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
GFD	Dermatome	Class I	General and plastic surgery	Contract sterilization	Oct 29, 2012
GFF	Bur, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Jan 8, 2013
GWO	Plate, Cranioplasty, Preformed, Alterable	Class II	Neurology	Contract sterilization	Nov 25, 2014
GXR	Cover, Burr Hole	Class II	Neurology	Contract sterilization	Nov 25, 2014
HAB	Saw, Powered, And Accessories	Class I	General and plastic surgery	Contract sterilization	Feb 27, 2013
HAO	Instrument, Surgical, Non-Powered	Class I	Neurology	Contract sterilization	Jun 28, 2013
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Class II	Neurology	Contract sterilization	Nov 25, 2014
HBW	Fastener, Plate, Cranioplasty	Class II	Neurology	Contract sterilization	Nov 25, 2014
HGI	Electrocautery, Gynecologic (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Nov 25, 2014
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	Class II	Ophthalmic	Contract sterilization	Nov 25, 2014
HJL	Lens, Condensing, Diagnostic	Class I	Ophthalmic	Contract sterilization	Feb 26, 2018
HMK	Euthyscope, Ac-Powered	Class II	Ophthalmic	Contract sterilization	Jul 11, 2017
HMQ	Marker, Sclera	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HMX	Cannula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNC	Specula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HND	Spatula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNF	Scissors, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNN	Knife, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNQ	Hook, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNR	Forceps, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 1, 2012
HNY	Cystotome	Class I	Ophthalmic	Contract sterilization	Nov 8, 2012
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Class I	Ophthalmic	Contract sterilization	Oct 29, 2012
HQL	Intraocular Lens	Class III	Ophthalmic	Contract sterilization	Nov 25, 2014
HRH	Trephine, Manual, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 16, 2012
HRK	Table, Instrument, Manual, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Nov 25, 2014
HRR	Scissors, Orthopedic, Surgical	Class I	Orthopedic	Contract sterilization	Nov 25, 2014
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Mar 16, 2018
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Jul 3, 2024
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract sterilization	Nov 15, 2019
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
HTD	Forceps	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
HTH	Protractor	Class I	Orthopedic	Contract sterilization	Nov 25, 2014
HTJ	Gauge, Depth	Class I	Orthopedic	Contract sterilization	Nov 25, 2014
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
HTO	Reamer	Class I	Orthopedic	Contract sterilization	Dec 4, 2012
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
HTZ	Instrument, Cutting, Orthopedic	Class I	General and plastic surgery	Contract sterilization	Nov 25, 2014
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
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	Dec 4, 2012
HXB	Probe	Class I	Orthopedic	Contract sterilization	Dec 4, 2012
HXJ	Staple Driver	Class I	Orthopedic	Contract sterilization	Nov 25, 2014
IWG	Seed, Isotope, Gold, Titanium, Platinum	Class II	Radiology	Contract sterilization	Nov 25, 2014
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
JEC	Component, Traction, Invasive	Class II	Orthopedic	Contract sterilization	Jul 3, 2024
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Class II	Clinical chemistry	Contract sterilization	Mar 21, 2013
JRL	Unit, Filter, Membrane	Class I	Clinical chemistry	Contract sterilization	Nov 16, 2012
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Oct 7, 2015
JZF	Tube, Ear Suction	Class I	Ear, nose and throat	Contract sterilization	Mar 18, 2013
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract sterilization	May 13, 2009
KEW	Slides, Microscope	Class I	Pathology	Contract sterilization	Nov 25, 2014
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	Nov 28, 2012
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract sterilization	May 7, 2013
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract sterilization	Jun 19, 2017
KQZ	Component, Traction, Non-Invasive	Class I	Orthopedic	Contract sterilization	Nov 15, 2012
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Jan 16, 2019
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract sterilization	Jul 3, 2024
KTZ	Caliper	Class I	Orthopedic	Contract sterilization	Nov 25, 2014
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
KXK	Source, Brachytherapy, Radionuclide	Class II	Radiology	Contract sterilization	Nov 25, 2014
KYB	Lens, Guide, Intraocular	Class I	Ophthalmic	Contract sterilization	May 2, 2013
LGZ	Warmer, Thermal, Infusion Fluid	Class II	General hospital	Contract sterilization	Feb 28, 2018
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
LRY	Punch, Surgical	Class I	General and plastic surgery	Contract sterilization	Oct 24, 2012
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	Jan 14, 2019
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Nov 25, 2014
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract sterilization	Mar 9, 2021
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Jan 16, 2019
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Apr 29, 2013
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
MIG	Strip, Test Isoniazid	Unclassified	Clinical toxicology	Contract sterilization	Jun 19, 2017
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Class III	Cardiovascular	Contract sterilization	Jan 16, 2019
MOS	Coil, Magnetic Resonance, Specialty	Class II	Radiology	Contract sterilization	Jun 19, 2017
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract sterilization	Jul 11, 2017
MUU	System, Suction, Lipoplasty	Class II	General and plastic surgery	Contract sterilization	Feb 3, 2022
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	Class I	General and plastic surgery	Contract sterilization	Oct 29, 2012
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
NDP	Accessories, Implant, Dental, Endosseous	Class I	Dental	Contract sterilization	Nov 9, 2012
NEC	Bandage, Liquid, Skin Protectant	Class I	General hospital	Contract sterilization	Nov 25, 2014
NEU	Marker, Radiographic, Implantable	Class II	General and plastic surgery	Contract sterilization	Oct 19, 2018
NUN	Bone Grafting Material, Human Source	Class II	Dental	Contract sterilization	Oct 19, 2018
OCT	Anti Fog Solution And Accessories, Endoscopy	Class II	Gastroenterology and urology	Contract sterilization	Nov 25, 2014
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract sterilization	Mar 9, 2021
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	Hematology	Contract sterilization	Jan 14, 2019
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract sterilization	Nov 15, 2019
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Class II	Orthopedic	Contract sterilization	Mar 22, 2021
PLF	Bone Wedge	Class II	Orthopedic	Contract sterilization	Mar 16, 2018
QHQ	Total Shoulder Arthroplasty System	Class II	Orthopedic	Contract sterilization	Mar 22, 2021
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unclassified	General and plastic surgery	Contract sterilization	Nov 25, 2014

Sterigenics U.S. LLC

Devices listed as contract work

Other contract facilities of Sotera Health LLC