Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008328679

FEI Number

3008328679

Entity Name

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

City/State/Country

Cuautitlan Izcalli Mexico, MX

Establishment Address

James Watt No. 22, Parque Industrial Cuamatla, Cuautitlan Izcalli Mexico CP 54730, 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

0707-002-000 Autoplex M4 Cement Mixer for Manifold with Vertaplex HV Bone Cement 0707-000-000 Autoplex M4 Cement Mixer with Vertaplex HV Bone Cement FLYTE SURGICOOL HOOD W/PEELAWAY FLYTE SURGICOOL HOOD (28/CS) 0408-801-400 Flyte SurgiCool Hood 0408-801-500 Flyte SurgiCool Hood, Peelaway 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 General Surgical Instrument ER2 Saturate Mixing System VORTEX & MIXOR NOZZLE UMBRELLA VORTEX ADAPTER VORTEX VACUUM MIXING SYSTEM VACUUM TUBE W/SUC BYPASS VORTEX & MIXOR NOZZLE ANGLED VORTEX VACUUM BOWL VORTEX&MIXOR NZLE STAND BRKAWY MIXOR FEMORAL PRESSURIZER-LG KYPHON® Mixer VORTEX RE-USE KIT VORTEX & MIXOR NOZZLE REVISION VORTEX&MIXOR NZLE LONG TAPERED 0206-548-000 0206-547-000 0206-556-000 0206-566-000 0206-545-000 0206-546-000 0206-509-000;0206-564-000 HiVac Bowl Bone Cement Mixing System B713 0506-482-000 0605-685-015 0606-573-000 0606-583-000 0306-564-000 0606-705-000 0506-689-015 0605-683-015 0606-595-000 0506-486-000 0606-509-000 MiniMix LV Bone Cement Mixing System SMLV 0605-687-015 0605-887-000 0506-685-015 0606-516-000 Medium Port MiniMix Bone Cement Mixing System SMMM1 RALLY Vacuum Mixing Bowl 7127-1801 0506-483-000 Mixing Bowl, Spatula B710 0606-593-000 0606-515-000 0606-517-000 0606-514-000 0707-001-000 AutoPlex M4 Cement Mixer 0506-489-000 0606-553-000S1 Kyphon Mixer 0606-705-000S1 0306-553-000S2 0506-485-000 0606-512-000 0606-593-000S1 0606-565-000 0506-686-015 0606-520-000 0506-683-015 0506-682-015 0606-518-000 0606-553-000 0606-563-000 0306-563-000 0306-573-000 0506-687-015 FLYTE HOOD W/PEELAWAY FLYTE PEELAWAY HOOD W/ WRAP Flyte Extended Hood w/Peelaway Flyte Extended Hood FLYTE HOOD FLYTE TOGA, PULLOVER XL FLYTE SURGICOOL TOGA, ZIPPER 3X FLYTE SURGICOOL TOGA, PULLOVER, 3X FLYTE SURGICOOL TOGA, PULLOVER, XL FLYTE SURGICOOL TOGA, ZIPPER FLYTE SURGICOOL TOGA, Zipper PEELAWAY, L FLYTE SURGICOOL TOGA, PULLOVER, 2X FLYTE SURGICOOL TOGA, PEELAWAY, 2X FLYTE SURGICOOL TOGA, ZIPPER, 2X FLYTE SURGICOOL TOGA, ZIPPER, L FLYTE SURGICOOL TOGA, PEELAWAY, 3X FLYTE SURGICOOL TOGA, PEELAWAY FLYTE SURGICOOL TOGA, PULLOVER, L 0408-841-100 Flyte Surgicool Toga, 2XL, Zipper, Peelaway 0408-851-000 Flyte Surgicool Toga, 3XL, Zipper 0408-821-100 Flyte Surgicool Toga, L, Zipper, Peelaway 0408-831-000 Flyte Surgicool Toga, XL, Zipper 0408-851-100 Flyte Surgicool Toga, 3XL, Zipper, Peelaway 0408-821-000 Flyte Surgicool Toga, L, Zipper 0408-741-000 Flyte Surgicool Toga, 2XL, Pullover 0408-751-000 Flyte Surgicool Toga, 3XL, Pullover 0408-831-100 Flyte Surgicool Toga, XL, Zipper, Peelaway 0408-841-000 Flyte Surgicool Toga, 2XL, Zipper 0408-731-000 Flyte Surgicool Toga, XL, Pullover FLYTE TOGA, PULLOVER, L FLYTE TOGA, ZIPPER, L FLYTE TOGA, PULLOVER, 3X FLYTE TOGA, PULLOVER, 2X FLYTE TOGA, ZIPPER, 3X FLYTE TOGA, ZIPPER, XL FLYTE TOGA, PEELAWAY XL FLYTE TOGA, ZIPPER, 2X FLYTE TOGA, PEELAWAY, L FLYTE TOGA PEELAWAY, 3X FLYTE TOGA, PEELAWAY, 2X 0416-831-100 T7Plus Zippered Toga with Peel Away 0416-841-200 T7Plus Zippered Toga 0416-750-200 T7 Pullover Toga 0416-820-200 T7 Zippered Toga 0416-821-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-830-100 T7 Zippered Toga with Peel Away Face Shield 0416-730-200 T7 Pullover Toga 0416-801-200 T7Plus Hood 0416-801-000 T7Plus Hood with Standard Face Shield 0416-851-200 T7Plus Zippered Toga 0416-731-200 T7Plus Pullover Toga 0416-851-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-830-200 T7 Zippered Toga 0416-841-100 T7Plus Zippered Toga with Peel Away Face Shield 0416-751-200 T7Plus Pullover Toga 0416-820-100 T7 Zippered Toga with Peel Away Face Shield 0416-850-200 T7 Zippered Toga 0416-831-200 T7Plus Zippered Toga 0416-850-100 T7 Zippered Toga with Peel Away Face Shield 0416-740-200 T7 Pullover Toga 0416-741-200 T7Plus Pullover Toga 0416-800-200 T7 Hood 0416-801-100 T7Plus Hood with Peel Away Face Shield 0416-821-200 T7Plus Zippered Toga 0416-721-200 T7Plus Pullover Toga 0416-840-200 T7 Zippered Toga 0416-840-100 T7 Zippered Toga with Peel Away Face Shield 0416-800-100 T7 Hood with Peel Away Face Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-06-05
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2025-07-29
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2025-07-29
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-10
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2010-06-11
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2012-10-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-03-17
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-10
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-10
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2026-05-05
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2026-05-05
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2026-05-05
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-10
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-10
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-15
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-15
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-02-21
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-02-21

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
9616517	Sterigenics S. de R.L. de C.V.	Tepeji del Rio de Ocampos Hidalgo, MX
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008328679. Last updated year: 2026. Please use registration number 3008328679 when referencing this establishment in official correspondence.