Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2219920

FEI Number

2219920

Entity Name

Sterigenics U.S., LLC

City/State/Country

Rockaway, NJ, US

Establishment Address

108 Lake Denmark Rd, Rockaway, NJ 07866, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Sotera Health LLC (Owner Number: 10029425)

Owner / Operator Contact Address

2015 Spring Road, Suite 650, Oak Brook, IL 60523, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NovaClips Greyhound Spring Clips Universal Plus Acessa Handpiece (previously known as Tulip RF Probe) PILLING Peak PlasmaBlade Plus DTF-13, TF-S, DTF-18, DTF-24, DTF-24b, DTF-31, 40990031, DTF-32, JSMDTF32, DTF-39, JSMDTF39, DTF-40, 4793.692, DTF-45, Ceruleau Peak PlsamaBlade Tonsil A2D, A8D, B1D, B2D, C3D, CV-B1, CV-B1/S, CV-B2, CV-B2/S, CV-B3, CV-B3/S, CV-L3, CV-L3/S, CV-L5, CV-L5/S, CV-L7, CV-L7/S, Olsen electrosurgical instruments and accessories ELECTROSURGICAL PENCIL Caiman TAP TAP II K862167 MINI TRACH II + 10/BX Portex Mini Tach II EM SA Implant System TYRX Absorbable Antibacterial Envelope Ocu-Film® + Tip Covers EM Provisional Attain Hybrid Guide Wire HG III ULTRA WIDE FIXTURE SYSTEM EXP-Pak¿ Access port for multiple instruments and/or cameras during minimally invasive abdominal laparospice surgery HIOSSEN IMPLANT SYSTEM TYRX Absorbable Antibacterial Envelope ET III Nano-HA Fixture System TYRX Absorbable Antibacterial Envelope Access port for multiple instruments and/or cameras during minimally invasive abdominal laparospice surgery IEC-BC Minor Surgery Bipolar Cable Sterile, Single-Use, (5 pcs) IEC-DJX Bipolar Cable, Sterile (10 pcs) IEC-BC/I Minor Surgery Bipolar Cable Sterile, Single-Use Intro Pkg Single Use Thermometers, Tempa-DOT,5122, 5125, 5532, 5538 Tempadot, Single use clinical thermometer Electrodes - Cynsure Ellman ELECTRODE, NEEDLE, 5 FR. 60CM NEUROENDOSCOPY ELECTRODE, BUTTON, 4 FR. ELECTRODE, COAGULATING BUTTON, 10 FR.,400 MM WL ELECTRODE, BUTTON, 3 FR. 3 FR., 260 MM WL ELECTRODE, COAGULATING BUTTON, 3 FR. ELECTRODE, COAGULATING BUTTON, 5 FR., 400 MM WL ETIV SA Dental Implants ET III BIO SA FIXTURE SYSTEM Access port for multiple instruments and/or cameras during minimally invasive abdominal laparospice surgery HT III SA FIXTURE SYSTEM TYRX Absorbable Antibacterial Envelope Access port for multiple instruments and/or cameras during minimally invasive abdominal laparospice surgery A-Oss®BONE GRAFTING MATERIAL, ANIMAL SOURCE InTrack Inserts DentoGen Iris retractor, disposable Iris Expander

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QES	Reherniation Reduction Device	Unknown	Class 3	N/A	2019-04-16
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2014-02-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-30
PRJ	Capillary Blood Collection Device For Alternative Site Collection	Clinical Chemistry	Class 2	862.1675	2018-08-31
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2012-11-20
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2012-11-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-04-29
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-11-13
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2012-11-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-04-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
PNL	Magnetic Surgical System	General, Plastic Surgery	Class 2	878.4815	2026-05-07
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2012-11-29
KJF	System, Suspension, Cell Culture	Hematology	Class 1	864.2240	2012-11-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-02-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-08-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-11-13
QJY	Infusion Pump, Drug Specific, Pharmacy-Filled	General Hospital	Class 2	880.5725	2025-05-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2024-09-26
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2024-09-26
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-11-13
QES	Reherniation Reduction Device	Unknown	Class 3	N/A	2019-04-16
OTJ	Laparoscopic Single Port Access Device	Gastroenterology, Urology	Class 2	876.1500	2013-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-21
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2014-03-26
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2013-08-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-04-29
PMU	Containment System, Laparoscopic Power Morcellation, With Instrument Port	Obstetrics/Gynecology	Class 2	884.4050	2018-08-31
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-08-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
OTJ	Laparoscopic Single Port Access Device	Gastroenterology, Urology	Class 2	876.1500	2013-02-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-02-21
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-08-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2020-11-13
OTJ	Laparoscopic Single Port Access Device	Gastroenterology, Urology	Class 2	876.1500	2013-02-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-02-21
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2021-04-22
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2021-04-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-08-31
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2018-08-31
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-11-29
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2012-11-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-31
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2012-11-08

Official Correspondent

Karen Whaley-Krumins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sotera Health LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005914490	UNIDADE DE ESTERILIZACAO COTIA LTDA.	Cotia Sao Paulo, BR
9680579	Sterigenics Radiation Technologies Canada, Inc	PORT COQUITLAM British Columbia, CA
3008132411	Sterigenics Shanghai E Beam Ltd.	Shanghai, CN
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX

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-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2219920. Last updated year: 2026. Please use registration number 2219920 when referencing this establishment in official correspondence.