Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245590

FEI Number

2245590

Entity Name

Sterigenics U.S., LLC

City/State/Country

Salem, NJ, US

Establishment Address

75 Tilbury Rd, Salem, NJ 08079, 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

A-Oss®BONE GRAFTING MATERIAL, ANIMAL SOURCE Bipolar Cords Monopolar Cords Eye Spheres / Conformers ETIII SA Fixture System (D3.2) implant ETIII SA Fixture System (D3.2) DISP. STD 3/4" BLUNT NEEDLE ELECTRODE DISP 3/4" NEEDLE ELECTRODE 24/BX COAG SUCT TUBE DISP W/STYLT 6" 10/BX DISP 6" EXTENDED NEEDLE ELECTRODE 24/BX COAG SUCT TUBE DISP W/STYLT 8" 10/BX DISP BICEPS FCPS CORD UNIV FIT 10/BX DISP 3/4" BLADE ELECTRODE 24/BX Suction Coagulator TMC¿ Tri-Optic Measurement Cell ETIV SA Dental Implants SimpleCAP X-TIP 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 Softips Automated Ophthalmics Softips ET III BIO SA FIXTURE SYSTEM Talymed Suspension ET III Nano-HA Fixture System ET II SA FIXTURE SYSTEM 07 0010 Samco Bio-Tite, 90mL, Midstream Kit with Funnel 02 0016 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap 02 0002 Cardinal Health Specimen Container, 90mL/48mm, ORG Cap container, specimen, sterile Vacuette No -Additive Tubes Clikseal Portex Speciman Trap Midstream Kit (Container Specimen) Pathology Container, Snap Cap, PN 0480-1101 Pathology Container, Snap Cap, PN 0450-1101 Pathology Container, Snap Cap, PN 0450-1111 1008/100 1002/36 Pathology Container, Snap Cap, PN 0501-1101 19227/12 B0810/50 Pathology Container, Snap Cap, PN 0480-1111 B0612/100 17531/50 B1708/50 TP002/50 1060/50 1050/50 PSS001/25 TP0014/50 B2923/50 B1212/25 17511/20 1005W/25 B1706/50 MHBFK01/10 JBQ773 1004/36 17531/20 PDC001/20 KB006L/20 B1111Z/25 B1912/100 B1710/100 1055/50 B1115Z/50 B0633/50 1013/100 1007/50 1070/50 SSB001/10 17555/50 B0606/25 BCP300/100 B0652/10 TP0015/50 17511C/20 TP0016/50 TP003/200 1001R/36 1055/75 SJMC001/10 B1215/100 Catch Kit: 25000 Speciman Cup: 8889207026 Corning Cryogenic vials and accessories Speciman Collection: 2600SA Catch Kit: 22000 Speciman Collection: 2090SA 430490 430661 430489 Speciman Container: 15000 Speciman Collection: 2205SA 431422 Speciman Collection: 2040SA Catch Kit: 22015 430663 430658 Speciman Collection: 2300SA Catch Kit: 25015 Speciman Collection: 2210SA 430659 430179 352001 Speciman Cup: 8889207067 Speciman Collection: 4090SA Speciman Container: 45117 Speciman Collection: 17099 Speciman Collection: 2200SA 352045 352006 Speciman Container: 14999 Speciman Container: 14000 431421 354015 Speciman Collection: 2650SA 352003 430488 Vitronova 431386 430487 430491 431418 430656 352037 431458 430492 354013 431420 431417 431419 430662 90ORG53-1001 90ORG53-1000 90WHT53-1000 SAMCO 90mL/53mm CLK SPC LBL WT CAP ST 5000-0020 Nalgene Cryogenic Tube, 2 mL externally-threaded 5005-0015 Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded 02 1090 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, ORG Cap 90WHT53-1001 Samco Clicktainer Vial, WHT Cap, 90mL, 53mm, w/lab, temp strip, ST 90ORG53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap 07 0002 Samco Bio-Tite, ST, 120mL, 53mm Midstream Kit No Funnel 03 0006 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, ORG Cap 07 0001 Samco Bio-Tite, ST, 90mL, 48mm Midstream Kit with Funnel 22-2090 Samco Bio-Tite Wide Mouth, ST, 90mL, 53mm, w/lab, YEL Cap 02 1016 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, WHT Cap 120WHT53-3000 Samco Clicktainer Vials, ST, 120mL, 53mm, Midstream Kit, no fnl 01 0001 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, ORG Cap CHB13905 Cardinal HealthTM Specimen Container, O/R Pouch 120mL/53mm 120ORG53-1000 Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, ORG Cap 90ORG53-1001 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, ORG Cap, dsp box 5005-0015 Nalgene Specimen Cryogenic Vial, 15 mL externally-threaded 02 0002 Cardinal HealthTM Specimen Container, 90mL/48mm, ORG Cap 01 0002 120ml/53mm SPCw/LBL, WH CAP,ST 02 0039 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, WHT Cap 120ORG53-4000 Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, ORG Cap 02 1038 Samco Bio-Tite Wide Mouth, ST 90mL, 53mm, w/lab, Natural Cap 02 0214 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, ORG Cap, dsp box CHB13904 Cardinal HealthTM Specimen Container 120mL/53mm 90WHT53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, WHT Cap 120ORG53-4000 22 610 131 Fisherbrand 60mL, 48mm, ST, w/lab and temp strip, WHT Cap 120WHT53-4000 03 0008 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, Green Cap 07 0020 Samco Bio-Tite, 120ml, Midstream Kit, no funnel CHB13903 Cardinal HealthTM Specimen Container 90mL/53mm 5000-0050 Nalgene Cryogenic Tube, 5 mL externally-threaded 01 0038 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap CHB13902 Cardinal HealthTM Specimen Container 90mL/48mm 120WHT53-1000 Samco Clicktainer Vials, ST, 120mL, 53mm, w/lab, WHT Cap 07 0000 Samco Bio-Tite Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap 90WHT53-1002 Samco Clicktainer Vial, ST, 90mL, 53mm, w/temp strip, WHT Cap 90GRN53-1000 Samco Clicktainer Vial, ST, 90mL, 53mm, w/lab, GRN Cap 03 0007 Samco Bio-Tite Narrow Mouth, ST 60mL, 48mm, w/lab, WHT Cap 02 0038 Samco Bio-Tite Narrow Mouth, ST 90mL, 48mm, w/lab, Natural Cap 120WHT53-4000 Samco Clicktainer Vials, ST, 120mL, 53mm, O/R Pouch, WHT Cap HT III SA FIXTURE SYSTEM Reusable Shielded Cable for concentric + single fiber EMG needle electrode Reusable Shielded Cable Reusable Unshielded Cable for detachable monopolar EMG needle electrode Electrode Cable Thayer Electrode Cable LW Cables and Lead Wires Tech-Attach Connection System CLE Cables and Lead Wires Cabrio Connection System Response EP Cables MYO/Wire® Disposiable Patient Cable 2 Reuasable Unshielded Cable Stimulation Clip MYO/Wire® Disposable Patient Cable 2 Reusable Unshielded Cable Neuroradium Universal Reusable Laryngeal Electrode Cable Reusable Shielded Cable for detachable monopolar EMG needle electrode Disposable Stimulation Clip SteriPrep¿ BrasselerLGI¿ HG III ULTRA WIDE FIXTURE SYSTEM Suction Coagulator HIOSSEN IMPLANT SYSTEM Suction Coagulator Single Wire and DoubleWire Sternum Sutures Algidex IV Algidex Paste impregnated gauze dressings intended for use as a primary contact layer in dressing wounds. oil emulsion, xeroform, petr Algidex Thin Film Algidex AG Algidex Dermanet Multidex Powder (various) Multidex Powder ET III SA ULTRA WIDE SYSTEM + (HEALING ABUTMENT)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2018-08-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-13
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2021-04-29
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2021-04-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-08-31
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2019-07-02
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-11-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-13
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2012-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-04-29
DZM	Needle, Dental	Dental	Class 1	872.4730	2012-12-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-30
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2012-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-07-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2010-06-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2012-11-12
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2012-11-08
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-08-31
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-11-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-02
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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-02
GAO	Suture, Nonabsorbable	General, Plastic Surgery	Class 2	878.4495	2012-11-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-11-13
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-10-31
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

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-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245590. Last updated year: 2026. Please use registration number 2245590 when referencing this establishment in official correspondence.