Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013820501

FEI Number

3013820501

Entity Name

Isomedix Operations Inc.

City/State/Country

Chester, NY, US

Establishment Address

2 Nucifora Blvd, Chester, NY 10918, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 9072619)

Owner / Operator Contact Address

5960 Heisley Road, --, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nellcor9703 (CH2) - Covidien LLC Nellcor9703 (CH2) - Covidien LLC Bayer1675 (CH2) - MEDRAD® Stellant FLEX 150 mL Sterile Disposable Syringe with Quick Fill Tube Bayer1675 (CH2) - MEDRAD Stellant Single Syringe Tri-Pak with Spike Bayer1675 (CH2) - MEDRAD Stellant Single Syringe Tri-Pak with QFT Bayer1675 (CH2) - MEDRAD® Stellant FLEX 150 mL Sterile Disposable Syringe with Spike Bayer1675 (CH2) - MEDRAD Dual Check Valve Transfer Set for MR Bayer1675 (CH2) - Stellant Single Syringe Tri-Pak Kit with QFT Bayer1675 (CH2) - Stellant Single Syringe Tri-Pak Kit with SPK NexxtSpine14118 (CH2) - NEXXT MATRIXX; TrellOss-C SA Bayer (CH2) - 50cm Low Pressure Connector Tubing Bayer1675 (CH2) - MEDRAD® MRXperion Multi-Patient Syringe Kit Bayer1675 (CH2) - MEDRAD Stellant 250cm Single Patient Disposable NexxtSpine14118 (CH2) - NEXXT MATRIXX®; TrellOss-A SA NexxtSpine14118 (CH2) - NEXXT MATRIXX; TrellOss Integra2421 (CH2) - OsteoStrux Osteo-conductive Scaffold-Putty Integra2421 (CH2) - Collage Osteo-conductive Scaffold-Putty Integra2421 (CH2) - OS Osteo-conductive Scaffold-Putty Nellcor9703 (CH2) - Covidien LLC Nellcor9703 (CH2) - Covidien LLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-31
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-03-31
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-05-06
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2022-03-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-03-30
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-03-30
QNI	Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair	Orthopedic	Class 2	888.3044	2022-01-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-03-31
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-09-18
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-01-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-03-28
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2025-09-18
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-08-19
QGA	Penile Implant Surgical Accessories	Gastroenterology, Urology	Class 1	876.3500	2022-11-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-01-31
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2025-09-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-09-18
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2022-04-05
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2025-09-18
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2022-04-05
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2022-03-30
NQR	Sealant, Dural	Unknown	Class 3	N/A	2017-09-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-09-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-03-30
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-08-19
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2022-03-25
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2022-03-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-09-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-08-19
OLC	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen	General, Plastic Surgery	Class 2	878.3300	2025-09-18
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-08-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-08-19
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2024-08-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-08-19
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-09-08
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2020-11-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-31
GGY	Pipette, Diluting	Hematology	Class 1	864.6160	2020-10-27
NQR	Sealant, Dural	Unknown	Class 3	N/A	2017-09-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013820501. Last updated year: 2026. Please use registration number 3013820501 when referencing this establishment in official correspondence.