Sterigenics U.S., LLC

Contract manufacturer and sterilizer · Haw River, NC

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

2009Product codes first listed, by year (tallest: 37)2026

FDA registration: 1036836 (openFDA record; or search FDA's registration database)
FEI number: 1036836
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer; Contract sterilizer
Owner or operator: Sotera Health LLC (FDA owner/operator no. 10029425)
Registered address: 1148 Porter Ave, Haw River, NC 27258
Contract listings: 88 device listings, 54 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
DWS	Instruments, Surgical, Cardiovascular	Class I	Cardiovascular	Contract sterilization	Nov 19, 2012
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract sterilization	Mar 21, 2018
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Oct 24, 2012
FMH	Container, Specimen, Sterile	Class I	Pathology	Contract sterilization	Jun 11, 2010
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract sterilization	Oct 14, 2019
FPF	Bottle, Hot/Cold Water	Class I	General hospital	Contract sterilization	Feb 9, 2024
FPY	Sheet, Burn	Class I	General hospital	Contract sterilization	Oct 29, 2012
FQH	Lavage, Jet	Class II	General hospital	Contract sterilization	Oct 31, 2012
FQM	Bandage, Elastic	Class I	General hospital	Contract sterilization	May 13, 2009
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract sterilization	Oct 31, 2012
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class II	General and plastic surgery	Contract sterilization	Oct 31, 2012
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Nov 1, 2012
GES	Blade, Scalpel	Class I	General and plastic surgery	Contract sterilization	Oct 31, 2012
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract sterilization	Oct 31, 2012
GIM	Tubes, Vacuum Sample, With Anticoagulant	Class II	Clinical chemistry	Contract sterilization	Mar 21, 2013
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
HPL	Device, Fixation, Ac-Powered, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Feb 9, 2024
HQC	Unit, Phacofragmentation	Class II	Ophthalmic	Contract sterilization	Oct 24, 2012
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Nov 1, 2012
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Oct 31, 2012
ITG	Bandage, Cast	Class I	Physical medicine	Contract sterilization	Nov 1, 2012
IZI	System, X-Ray, Angiographic	Class II	Radiology	Contract sterilization	Oct 31, 2012
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Class II	Clinical chemistry	Contract manufacturing	Dec 2, 2019
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
KDT	Container, Specimen Mailer And Storage, Sterile	Class I	Pathology	Contract sterilization	Nov 16, 2012
KIZ	Dish, Tissue Culture	Class I	Hematology	Contract sterilization	Nov 1, 2012
KJA	Flask, Tissue Culture	Class I	Hematology	Contract sterilization	Aug 14, 2009
KKX	Drape, Surgical, Antimicrobial	Class II	General and plastic surgery	Contract sterilization	Oct 31, 2012
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract sterilization	May 7, 2013
KPE	Container, I.V.	Class II	General hospital	Contract sterilization	Mar 14, 2018
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Class I	Clinical chemistry	Contract sterilization	Nov 1, 2012
LYU	Accessory, Surgical Apparel	Class I	General and plastic surgery	Contract sterilization	Dec 4, 2012
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Oct 31, 2012
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unclassified	General and plastic surgery	Contract sterilization	Oct 31, 2012
MQH	Microtools, Assisted Reproduction (Pipettes)	Class II	Obstetrics and gynecology	Contract sterilization	Oct 31, 2012
MQX	Needle, Acupuncture, Single Use	Class II	General hospital	Contract sterilization	Jul 5, 2018
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	Class I	General and plastic surgery	Contract sterilization	Mar 14, 2018
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Oct 31, 2012
NDP	Accessories, Implant, Dental, Endosseous	Class I	Dental	Contract sterilization	Nov 9, 2012
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	Contract sterilization	Mar 21, 2018
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	Class II	General and plastic surgery	Contract sterilization	Oct 31, 2012
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Class III	Cardiovascular	Contract sterilization	Feb 9, 2024
OCT	Anti Fog Solution And Accessories, Endoscopy	Class II	Gastroenterology and urology	Contract sterilization	Oct 31, 2012
ORZ	Eyelid Thermal Pulsation System	Class II	Ophthalmic	Contract sterilization	Nov 16, 2012
OTZ	Graft Insertion Instrument For Endothelial Keratoplasty	Class I	Ophthalmic	Contract sterilization	Oct 31, 2012
PJE	Blood/Plasma Collection Device For Dna Testing	Class II	Clinical chemistry	Contract sterilization	Mar 21, 2013
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	Class II	General and plastic surgery	Contract sterilization	Jun 29, 2018

Sterigenics U.S., LLC

Devices listed as contract work

Other contract facilities of Sotera Health LLC