Isomedix Operations Inc.

Contract sterilizer · Grand Prairie, TX

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

2012Product codes first listed, by year (tallest: 19)2026

FDA registration: 1650907 (openFDA record; or search FDA's registration database)
FEI number: 3002681132
Registered for: FDA registration year 2026
Establishment types: Manufacturer for export only; Contract sterilizer
Owner or operator: STERIS Corporation (FDA owner/operator no. 9072619)
Registered address: 1175 Isuzu Pkwy, Grand Prairie, TX 75050
Contract listings: 140 device listings, 72 product codes, first listed Oct 30, 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
DQA	Oximeter	Class II	Cardiovascular	Contract sterilization	Nov 6, 2023
DQK	Computer, Diagnostic, Programmable	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
DYB	Introducer, Catheter	Class II	Cardiovascular	Contract sterilization	Jun 23, 2023
EOB	Nasopharyngoscope (Flexible Or Rigid)	Class II	Ear, nose and throat	Contract sterilization	Apr 12, 2023
EOQ	Bronchoscope (Flexible Or Rigid)	Class II	Ear, nose and throat	Contract sterilization	Apr 12, 2023
FAJ	Cystoscope And Accessories, Flexible/Rigid	Class II	Gastroenterology and urology	Contract sterilization	Apr 12, 2023
FEQ	Pump, Air, Non-Manual, For Endoscope	Class II	Gastroenterology and urology	Contract sterilization	Jan 8, 2025
FHM	Apparatus, Suturing, Stomach And Intestinal	Class I	General and plastic surgery	Contract sterilization	Aug 4, 2025
FIB	Protector, Transducer, Dialysis	Class II	Gastroenterology and urology	Contract sterilization	Dec 17, 2012
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class II	Gastroenterology and urology	Contract sterilization	Oct 30, 2012
FKX	System, Peritoneal, Automatic Delivery	Class II	Gastroenterology and urology	Contract sterilization	Dec 17, 2012
FRZ	Device, Patient Transfer, Powered	Class II	General hospital	Contract sterilization	Sep 28, 2023
FZP	Clip, Implantable	Class II	General and plastic surgery	Contract sterilization	Jun 2, 2025
GAG	Stapler, Surgical	Class II	General hospital	Contract sterilization	Sep 25, 2024
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Jun 24, 2013
GDJ	Clamp, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract sterilization	Aug 4, 2025
GDW	Staple, Implantable	Class II	General and plastic surgery	Contract sterilization	Mar 24, 2023
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Jun 24, 2013
HGI	Electrocautery, Gynecologic (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Mar 24, 2023
HIH	Hysteroscope (And Accessories)	Class II	Obstetrics and gynecology	Contract sterilization	Oct 7, 2020
HMT	Drape, Patient, Ophthalmic	Class II	General and plastic surgery	Contract sterilization	Dec 17, 2012
HMX	Cannula, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Dec 19, 2024
HNO	Keratome, Ac-Powered	Class I	Ophthalmic	Contract sterilization	Nov 9, 2021
HQB	Photocoagulator And Accessories	Class II	Ophthalmic	Contract sterilization	Dec 19, 2024
HQC	Unit, Phacofragmentation	Class II	Ophthalmic	Contract sterilization	Dec 17, 2012
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Class II	Ophthalmic	Contract sterilization	Nov 9, 2021
HQF	Laser, Ophthalmic	Class II	Ophthalmic	Contract sterilization	Jul 11, 2024
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Class II	Ophthalmic	Contract sterilization	Dec 17, 2012
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Jun 24, 2013
ITX	Transducer, Ultrasonic, Diagnostic	Class II	Radiology	Contract sterilization	Aug 4, 2025
IWJ	System, Applicator, Radionuclide, Manual	Class I	Radiology	Contract sterilization	Aug 4, 2025
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Class II	Radiology	Contract sterilization	Aug 4, 2025
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Class II	Radiology	Contract sterilization	Aug 4, 2025
JOW	Sleeve, Limb, Compressible	Class II	Cardiovascular	Contract sterilization	Jun 24, 2013
KCY	Tourniquet, Pneumatic	Class I	General and plastic surgery	Contract sterilization	Nov 6, 2023
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Class II	Gastroenterology and urology	Contract sterilization	Dec 17, 2012
KGX	Tape And Bandage, Adhesive	Class I	General hospital	Contract sterilization	Nov 16, 2012
KOC	Accessories, Blood Circuit, Hemodialysis	Class II	Gastroenterology and urology	Contract sterilization	Dec 17, 2012
KXG	Applicator, Absorbent Tipped, Sterile	Class I	General hospital	Contract sterilization	Dec 20, 2012
KYB	Lens, Guide, Intraocular	Class I	Ophthalmic	Contract sterilization	Dec 17, 2012
LDF	Electrode, Pacemaker, Temporary	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
LFL	Instrument, Ultrasonic Surgical	Unclassified	General and plastic surgery	Contract sterilization	Mar 24, 2023
LNH	System, Nuclear Magnetic Resonance Imaging	Class II	Radiology	Contract sterilization	Aug 4, 2025
LPB	Cardiac Ablation Percutaneous Catheter	Class III	Cardiovascular	Contract sterilization	Jan 5, 2021
LRO	General Surgery Tray	Class II	General and plastic surgery	Contract sterilization	Dec 17, 2012
MLZ	Vitrectomy, Instrument Cutter	Class II	Ophthalmic	Contract sterilization	Dec 17, 2012
MNL	Accessories, Cleaning Brushes, For Endoscope	Class I	Gastroenterology and urology	Contract sterilization	Jan 8, 2025
MPA	Endoilluminator	Class II	Gastroenterology and urology	Contract sterilization	Dec 19, 2024
MQE	Needle, Assisted Reproduction	Class II	Obstetrics and gynecology	Contract sterilization	Aug 4, 2025
MTD	Catheter, Intracardiac Mapping, High-Density Array	Class II	Cardiovascular	Contract sterilization	Jan 5, 2021
NAB	Gauze / Sponge,Nonresorbable For External Use	Class I	General and plastic surgery	Contract sterilization	Dec 20, 2012
NAY	System, Surgical, Computer Controlled Instrument	Class II	Gastroenterology and urology	Contract sterilization	Jun 22, 2023
NGY	Cannula, Trocar, Ophthalmic	Class I	Ophthalmic	Contract sterilization	Apr 8, 2024
NLF	Oximeter, Reprocessed	Class II	Cardiovascular	Contract sterilization	Jun 24, 2013
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Class II	Gastroenterology and urology	Contract sterilization	Jun 24, 2013
NLQ	Single-Use Reprocessed Ultrasonic Surgical Instruments	Unclassified	General and plastic surgery	Contract sterilization	May 8, 2014
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	Class II	General and plastic surgery	Contract sterilization	Jun 24, 2013
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Class III	Cardiovascular	Contract sterilization	Jan 5, 2021
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Class III	Cardiovascular	Contract sterilization	Jan 5, 2021
OCW	Endoscopic Tissue Approximation Device	Class II	Gastroenterology and urology	Contract sterilization	Jun 2, 2025
OCX	Endoscopic Irrigation/Suction System	Class II	Gastroenterology and urology	Contract sterilization	Jan 8, 2025
ODC	Endoscope Channel Accessory	Class II	Gastroenterology and urology	Contract sterilization	Jan 8, 2025
ODX	Autonomous Extracorporeal Blood Leak Detector/Alarm	Class II	Gastroenterology and urology	Contract sterilization	Jan 23, 2020
OJK	Eye Tray	Class II	Ophthalmic	Contract sterilization	Sep 22, 2025
ONW	Hemodialysis System For Home Use	Class II	Gastroenterology and urology	Contract sterilization	Jan 23, 2020
OOE	Ophthalmic Femtosecond Laser	Class II	Ophthalmic	Contract sterilization	Nov 9, 2021
PUI	Drape, Surgical, Exempt	Class II	General and plastic surgery	Contract sterilization	Aug 1, 2023
PZG	Surgical Eye Tray	Class I	Ophthalmic	Contract sterilization	Sep 22, 2025
QDV	Iol Tray	Class I	Ophthalmic	Contract sterilization	Sep 22, 2025
QDW	Phaco Kit	Class II	Ophthalmic	Contract sterilization	Sep 22, 2025
QDY	Vitrectomy Kit	Class II	Ophthalmic	Contract sterilization	Sep 22, 2025

Isomedix Operations Inc.

Devices listed as contract work

Other contract facilities of STERIS Corporation