Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010407203

FEI Number

3010407203

Entity Name

Sterigenics Italy SpA

City/State/Country

Minerbio Bologna, IT

Establishment Address

via Marzabotto 4, Minerbio Bologna 40061, IT

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

Visitec Applicator Absorbent tipped Sterile Nylon fiber swab sterile NuFoamSwabs BD BBL Flocked Swab CLASSIQSwabs FLOQSwabs Rayon fiber swab sterile Polyester fiber swab sterile Foam swab sterile Cotton fiber swab sterile Rovers Anex Brush Rovers Anex Brush RT 9312M/50 9305/50 9320/100 9399/50 9740/50 9706/25 9625D/100 9713/50 S FPDLRS 0100 R02401 FBB {FIRST AID 100/24 STER WRAP} 9312/100 19602/20 9714/50 9702/50 96100/10 9605M/100 9606/100 9612P/100 9612D/100 9606M/100 9612/100 9325/100 9311P/100 9325D/100 9610G/100 9306/100 9318/100 9733/50 9310/100 9606/50 9712/100 9736/50 9605/100 9706/100 9650/50 9625/100 S SDDLR 0125 R03606 FBB {FIRST AID SWABS 36/125 WD 6PK} 9305/100 9710/25 9603M/100 9716/50 9350/100 9705/50 9716/25 9606L/100 9320P/100 9706/50 9620/100 9605/50 9350P/100 96110/50 9610/100 9703/50 9615/25 9310P/100 9611/100 96100/50 9718/100 Techniswab Rovers Evalyn Brush Microbrush Test Swabs Instruments, Surgical, Cardiovascular NAMIC¿ Bottle/SOSA¿ Spike Clip NAMIC¿ Bottle/SOSA¿ Spike Clip ONLY Sterile Handle sterilized AORTIC PUNCH (APU PRODUCT FAMILY) Assistant with StableSoft - 3S Assistant with StableSoft - 3L Cutter Contamination Sleeve Assistant with StableSoft - 2S Assistant with StableSoft - 2L Assistant with StableSoft 3S Flex Worely Slitter Assistant with StableSoft 3L Flex Transavalvular Insertion Tool (TVI) Polyester Tape ELIZABETH Lead Clippers V-CATH INSERTION KIT Hemashield Finesse Ultrathin, Knitted Cardiovascular Patch Dental implants BT-Tite One (BTICV1) and abutments Dental implants BT-Tite CV2 (BTICV2) Dental implants BT-Tite Standard (BTIVSM) InterGard Woven InterGard Woven Collagen Coated Vascular Prostheses Mini implants Mini Single implants Slot implants (BTISI) Dental implants BT-Tite CV3 (BTICV3) 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 TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS DIALYSIS KIT MEDICAL DEVICES INTERNATIONAL (MDI)- Drainage Bags Drainage Bag Extension Tubing MEDICAL DEVICES INTERNATIONAL Conveen Contour Conveen Security+ SPIDER SCREW - STERILE Hemashield Microvel Velour Knitted Vascular Graft COPS1 HS10F 200CS01 COPH10 CST-H10 HLS10LT 212CS20 HST10F CST-H1 COP-MIN 200CS10 229CS01 223CS20 HS1F CST-S10 200CS05 224CS20 COP-NED HLH1ST HS1R 201CS10 CT50-S1 212CS05 INFS10 HLS10ST HLT10R 201CS01 BIOASSAY DISH, LOW PROFILE PS COPTS-5 COPTS-10 INFH1 212CS01 HST10R HLT10F HLS1ST INF-NED HST1F CD179S01 CD178S01 COPH1 HS10R CST-NED 224CS01 CD177S01 CST-S1 209CS20 COPTS-01 201CS20 HLT1R HLNEDLT CT50-H1 CT50-S10 202CS01 COPS10 HLT1F 218CS20 222CS10 COPTS10ZL 223CS01 HLS1LT 202CS20 HST1R INFH10 INFS1 200CS30 HSTND HSND 222CS01 HLNEDST Rondo Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts Hemagard Carotid patch HemaCarotid Patch HemaPatch Vascular Patches InterGard Knitted Hemagard Knitted InterGard and Intergard RS Vascular Prostheses HemaPatch Compressed Gauze Richmond Dental & Medical Gauze/sponge,nonresorbable for external use 7182/100 19604/50 KA2525/20 7825/24 7195/100 7172/50 4457/20 2636/25 7725/50 17474/20 7185/50 2648/24 908110 - Venture 2638/20 7870/20 4452/20 17480/20 9204/50 7120/50 2637/20 4425/24 7602/24 7737/50 7173/50 7040/50 7135/50 4455/20 7440/50 7188/50 7190/20 13636/24 7140/50 7125/50 7810/24 7502/24 11212/24 KA2550/25 4451/20 KA2540/20 7180/50 7150/50 4445/24 KA2520/20 7020/25 7176/50 17442/24 7172W/50 7706/50 908115 - Venture 7612/20 4415/24 7610/30 KA2580/50 KA2535/25 7210/25 7132/50 7733/50 7186/50 7720/50 2660/20 4435/24 11818/24 4456/20 7533/24 7504K/25 7510/24 7010/50 19401/20 KA25158/25 7130/50 908276 - Venture 7604K/24 7243/50 7880/20 7145/50 7806/24 7736/50 7746/50 7177/25 2680/20 2670/25 KA2530/25 KP1101/50 908272 - Venture TACgauze GAUZE ROLL BURN DRESSING TRICOTEX (PROFORE wound contact layer) Mercocel Venture Brand Gauze/Sponge Guide Wire Insertion Device BowTie GABBAY-FRATER 1.3MM X 2.7MM DRILL GUIDE DTRAX Spinal System P-L VLP UNIV DRILL GDE HANDLE W PVT HD MEDTRONIC Facet Screw Instruments TRIPLE DRILL GUIDE Prostate Needle Guide KYPHON® Introducer Tool Kit THE SNAKE Zimmer Guide Pin Facet Screw Insruments Ad-Tech Sleeve Guides Wire Caddy Needle Guide Guide, surgical, instrument LAA Selection Guide Endovis B.A. Dinamic T Humerus KA2210/25 KA2110/50 TRU-FIX Catheter Fixation Kit KA1224/50 KA2210/50 KA1154/25 KA2254/25 KA1124/100 KA2310W/25 KA2154/50 MTS003/100 KA2130/50 KA1124/25 Zip DS Dressing Shield Bandages KA1118/50 KA2211/25 KA1254/25 OPSITE, IV3000 Frame Delivery COVRSITE Plus OPSITE, IV3000 1-Hand Breg OPSITE, IV3000 1-Hand Ported OPSITE Post Op, IV 3000 OPSITE Flexigrid, IV3000 Standard Skin Fix OPSITE Flexigrid, IV3000 Ported Tape & Bandage, Adhesive - 004792,004793,004794,004795, 004796,002970,003008,003276, 004342,003175,004322,005121, 005001 Incise Film BAND-AID® Brand TOUGH STRIPS® Bandages TrialOn BAND-AID® Brand Flexible Fabric Bandages Tube Holder 100/case Tube Holder White Dressings (Breg) SureSeal Pressure Bandage Primapore CovRsite 728NL-20S MICRO PIPETTE 204-1S MICRO PIPETTE 335-1S MICRO PIPETTE 232NL-1S MICRO PIPETTE 225NL-1S MICRO PIPETTE 252NL-20S MICRO PIPETTE 212NL-1S MICRO PIPETTE 704NL-25S MICRO PIPETTE 805NL-10S MICRO PIPETTE 691-1S MICRO PIPETTE 251-20S MICRO PIPETTE 212-20S MICRO PIPETTE 222NL-10S MICRO PIPETTE 202NL-20S MICRO PIPETTE 263NL-1S MICRO PIPETTE 273-1S MICRO PIPETTE 001-1095 MICRO PIPETTE 282NL-1 MICRO PIPETTE 262NL-1S MICRO PIPETTE 9702931 MICRO PIPETTE 263-20S MICRO PIPETTE 86.117201 MICRO PIPETTE ES21612A MICRO PIPETTE 235-20S MICRO PIPETTE 282-20S MICRO PIPETTE 242NL-1S MICRO PIPETTE 232NL-20S MICRO PIPETTE 234-1S MICRO PIPETTE 694NL-10S MICRO PIPETTE 86.117520 MICRO PIPETTE 282-1S MICRO PIPETTE 806NL-20S MICRO PIPETTE 0378000 MICRO PIPETTE 234-20S MICRO PIPETTE 225-20SFDB MICRO PIPETTE 212-1S MICRO PIPETTE 200120 MICRO PIPETTE 242-1S MICRO PIPETTE 232-10S MICRO PIPETTE 263-1S MICRO PIPETTE 274-1S MICRO PIPETTE 234NL-1S MICRO PIPETTE 759NL-1S MICRO PIPETTE 336-10S MICRO PIPETTE 222NL-20S MICRO PIPETTE 262-1S MICRO PIPETTE 357575 MICRO PIPETTE 263NL-20S MICRO PIPETTE 761NL-1S MICRO PIPETTE 241NL-1S MICRO PIPETTE 274NL-1S MICRO PIPETTE 202NL-1S MICRO PIPETTE 335-20S MICRO PIPETTE 225-1S MICRO PIPETTE 804NL-20S MICRO PIPETTE 225NL-20S MICRO PIPETTE 202-1S MICRO PIPETTE 13-711-9C MICRO PIPETTE 86.117320 MICRO PIPETTE 273-20S MICRO PIPETTE 001-1020 MICRO PIPETTE 13-711-9B MICRO PIPETTE 691-20S MICRO PIPETTE 274-20S MICRO PIPETTE 262NL-20S MICRO PIPETTE 225-20S MICRO PIPETTE 728NL-1S MICRO PIPETTE 001-1618 MICRO PIPETTE 274NL-20S MICRO PIPETTE 262-10S MICRO PIPETTE 222-10S MICRO PIPETTE ES21212D MICRO PIPETTE 233-1S MICRO PIPETTE 694-1S MICRO PIPETTE 222NL-1S MICRO PIPETTE 202-10S MICRO PIPETTE ES21112D MICRO PIPETTE 202-20S MICRO PIPETTE 86.117301 MICRO PIPETTE 262-20S MICRO PIPETTE 225-1S-400 MICRO PIPETTE 231NL1S-25 MICRO PIPETTE 13-711-9BM MICRO PIPETTE 282-22S MICRO PIPETTE 300-8533 MICRO PIPETTE 13-711-9CM MICRO PIPETTE 803NL-10S MICRO PIPETTE 251-1S MICRO PIPETTE 231NL-20S MICRO PIPETTE 86.117101 MICRO PIPETTE 336NL-20S MICRO PIPETTE 98-06155-00 MICRO PIPETTE 336NL-1S MICRO PIPETTE 231-20S MICRO PIPETTE 204-20S MICRO PIPETTE 13-711-20 MICRO PIPETTE 234NL-20S MICRO PIPETTE 242NL-20 MICRO PIPETTE 336-20S MICRO PIPETTE 204NL-1S MICRO PIPETTE 86.117220 MICRO PIPETTE 222-20S MICRO PIPETTE 233NL-20S MICRO PIPETTE 242-20S MICRO PIPETTE 232-1S MICRO PIPETTE 282NL-20S MICRO PIPETTE 86.117420 MICRO PIPETTE 242NL-20S MICRO PIPETTE 691NL-20S MICRO PIPETTE 703NL-25S MICRO PIPETTE 86.117120 MICRO PIPETTE 212NL-20S MICRO PIPETTE 252-20S MICRO PIPETTE 204NL-20S MICRO PIPETTE 232-20S MICRO PIPETTE 262NL-10S MICRO PIPETTE 235NL-1S MICRO PIPETTE 231NL-1S MICRO PIPETTE 282NL-1S MICRO PIPETTE 222-1S MICRO PIPETTE 233-20S MICRO PIPETTE 233NL-1S MICRO PIPETTE 336-1S MICRO PIPETTE 231NL1S-12 MICRO PIPETTE 231-1S MICRO PIPETTE 691NL-1S MICRO PIPETTE 252-1S MICRO PIPETTE 1660474 MICRO PIPETTE 235-1S MICRO PIPETTE 273NL-1S MICRO PIPETTE 974NL1S-12 MICRO PIPETTE Hemashield Platinum Woven Double Velour TAAA Graft configuration Graft-Sizer Slide Fix Jars VIAL W/CAP InterGard Aortic Arch InterGard HemaBridge InterGard HemaBridge Collagen Coated Vascular Prosthesis InterGard Aortic Arch Collagen Coated Vascular Prosthesis SELF LIGATING SPIDER SCREW - STERILE WINSIX IMPLANT WINSIX Hemashield KNitted Double Velour Cardiovascular Fabric Intergard Cardioroot Woven Vascular Graft Intervascular Cardioroot Vascular Graft Maquet Cardioroot Vascular Graft Cardioroot Woven Collagen Coated Vascular Prostheses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2013-05-02
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-11-19
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-09-30
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-02-01
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-03-11
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2023-09-25
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-02-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-02-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-02-01
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2010-06-11
FKG	Tray, Start/Stop (Including Contents), Dialysis	Gastroenterology, Urology	Class 1	876.5820	2017-04-26
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	Class 2	882.5330	2019-07-02
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2019-07-02
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2012-12-12
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-02-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2016-02-01
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2022-09-30
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2012-11-01
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2024-09-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-02-12
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2018-02-12
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2022-09-30
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2023-09-25
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2018-02-12
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2012-10-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-11-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-02-12
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-11-12
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2018-02-12
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2012-11-30
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2020-03-11
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2020-03-11
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2022-09-30
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2022-09-30
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2012-11-16
JTW	System, Transport, Aerobic	Microbiology	Class 1	866.2900	2018-02-12
JTX	Transport Systems, Anaerobic	Microbiology	Class 1	866.2900	2018-02-12
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-09-08
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2023-09-25
JSL	Culture Media, Anaerobic Transport	Microbiology	Class 1	866.2390	2018-02-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-07-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-07-24
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2016-02-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-02-12
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2022-09-30
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2023-09-25

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
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
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
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 3010407203. Last updated year: 2026. Please use registration number 3010407203 when referencing this establishment in official correspondence.