Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616517

FEI Number

3003117688

Entity Name

Sterigenics S. de R.L. de C.V.

City/State/Country

Tepeji del Rio de Ocampos Hidalgo, MX

Establishment Address

Parque Industrial Tepeji, Calle North 7 s/n, Tepeji del Rio de Ocampos Hidalgo CP 42850, MX

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

Xi Seal (5 to 8mm) - 470361 5-8 mm Cannula Seal - 470361 560 ISO S P P C C E W144 140 560 ISO S P P C C E W144 90 - 140 LEXICON ABS S P P ISO W180 15 565 AUXILIARY S P P W144 X C 560 ISO S P P C C E W180 50 560 ISO S P P C C E W180 35 ABSORBENT S P P MAILLEFER W180 60 560 ISO S P P C C E W180 40 560 ISO S P P C C E W180 15 - 40 560 ISO S P P C C E W180 30 LEXICON ABS S P P ISO W180 45-80 ABSORBENT S P P MAILLEFER W180 XXF-XC ABSORBENT S P P MAILLEFER W180 70 LEXICON ABS S P P ISO W180 15-40 560 ISO S P P C C E W180 20 ABSORBENT S P P MAILLEFER W180 F ABSORBENT S P P MAILLEFER W180 C 565 AUXILIARY S P P W180 F 560 ISO S P P C C E W180 15 560 ISO S P P C C E W180 45 560 ISO S P P C C E W144 90 560 ISO S P P C C E W144 100 LEXICON ABS S P P ISO W180 20 LEXICON ABS S P P ISO W180 25 ABSORBENT S P P MAILLEFER W180 XF LEXICON ABS S P P W180 F ABSORBENT S P P MAILLEFER W180 55 LEXICON ABS S P P ISO W180 55 565 AUXILIARY S P P W180 XXF-C 560 ISO S P P C C E W144 130 560 ISO S P P C C E W180 25 ABSORBENT S P P MAILLEFER W180 20 ABSORBENT S P P MAILLEFER W180 30 LEXICON ABS S P P ISO W180 50 560 ISO S P P C C E W180 80 ABSORBENT S P P MAILLEFER W180 M LEXICON ABS S P P W180 XF LEXICON ABS S P P W180 XXF-XC ABSORBENT S P P MAILLEFER W180 15-40 ABSORBENT S P P MAILLEFER W180 15 560 ISO S P P C C E W180 70 ABSORBENT S P P MAILLEFER W180 45 560 ISO S P P C C E W180 60 565 AUXILIARY S P P W180 M ABSORBENT S P P MAILLEFER W180 35 560 ISO S P P C C E W180 55 LEXICON ABS S P P ISO W180 40 ABSORBENT S P P MAILLEFER W180 25 LEXICON ABS S P P ISO W180 80 ABSORBENT S P P MAILLEFER W180 XC LEXICON ABS S P P W180 M LEXICON ABS S P P ISO W180 30 ABSORBENT S P P MAILLEFER W180 50 ABSORBENT S P P MAILLEFER W180 40 ABSORBENT S P P MAILLEFER W180 80 565 AUXILIARY S P P W180 XX F 560 ISO S P P C C E W144 110 LEXICON ABS S P P W180 X-C LEXICON ABS S P P ISO W180 70 LEXICON ABS S P P W180 C LEXICON ABS S P P ISO W180 45 565 AUXILIARY S P P W180 C LEXICON ABS S P P ISO W180 60 560 ISO S P P C C E W144 120 560 ISO S P P C C E W180 45 - 80 ABSORBENT S P P MAILLEFER W180 45-80 LEXICON ABS S P P ISO W180 35 565 AUXILIARY S P P W180 X F Precise Dental 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 Ocu-Dot Tonometer Probes-100 Count Ocu-Film® + Tip Covers Xi Conductive Reducer - 470381 Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09) Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07) Si Stapler Sheath - 410370 Xi Stapler 45 Reload (Blue) - 48645B Xi Seal (12mm & Stapler) - 470380 12 mm & Stapler Cannula Seal - 470380 Xi Stapler 45 Reload (White) - 48645W Xi Stapler 45 Reload (Green) - 48445G Xi Optical Obturator (12mm & Stapler, Standard), (470403-01 &-02) Xi Optical Obturator (12mm & Stapler, Long), (470404-01 & -02) Xi Optical Obturator (8mm, Standard), (470359-01 &-02) Xi Optical Obturator (8mm, Long), (470360-01 &-02) Xi Optical Obturator (12mm & Stapler, Standard) - 470403 8 mm Bladeless Obturator - 470359 Xi Optical Obturator (12mm & Stapler, Long) -470404 Xi Optical Obturator (8mm, Standard) - 470359 Xi Optical Obturator (8mm, Long) - 470360 8 mm Bladeless Obturator, Long - 470360

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2013-01-28
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2010-06-11
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2025-05-20
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2012-11-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-07-05
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-07-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-05

Official Correspondent

Karen Whaley-Krumins

US Agent Details

Chris Eustace Email: ceustace@sterigenics.com Phone: (630) 9281700

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
3008328679	Sterigenics S. de R.L. de C.V.	Cuautitlan Izcalli Mexico, MX
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616517. Last updated year: 2026. Please use registration number 9616517 when referencing this establishment in official correspondence.