Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807090

FEI Number

3006003617

Entity Name

Sterigenics Germany GmbH

City/State/Country

Wiesbaden Hesse, DE

Establishment Address

Kasteler Straße 45, Wiesbaden Hesse D-65203, DE

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

ROTAFLOW Centrifugal Pump with BIOLINE Coating FLYTE HOOD W/PEELAWAY FLYTE PEELAWAY HOOD W/ WRAP Flyte Extended Hood w/Peelaway Flyte Extended Hood FLYTE HOOD FLYTE SURGICOOL HOOD W/PEELAWAY FLYTE SURGICOOL HOOD (28/CS) 0408-801-400 Flyte SurgiCool Hood 0408-801-500 Flyte SurgiCool Hood, Peelaway QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating "BMU Cell ½¿, 3/8¿, ¼¿,BMU Sensor 3/8¿, ¼¿, 3/16¿ Jackson-Pratt Wound Drainage Devices TRU-CLOSE Suction Drainage System Suction Reservoir Kit 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 Arterial HLS-Cannula, 13 Fr., non-coated, with BIOLINE and with SOFTLINE Coating Percutaneous Insertion Kits HLS-Set Advanced 7 and 5 HIT-Set Advanced 7 and 5 QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating "QUADROX-iR Adult / Small Adult, with and without integrated Arterial Filter, with BIOLINE or SOFTLINE Coating; CranialMask Tracker FRAMELESS GUIDE T401261 Atlas Positioner T401209S Assitant with StableSoft 3L Atlas 360 Positioner Ultra Titan Stabilizer Long Shaft Attachment Titan Ultra Stabilizer Attachment T401245 StableSoft II Stabilizer - Long Shaft T401211S Assistant with StableSoft 2L T401231LS Titan Stabilizer Long Shaft JANKE-BARRON HEART SUPPORT T401231 Titan Stabilizer T401212S Assistant with StableSoft 2S T401210S Assistant with StableSoft 3S T401231U Titan 360 Stabilizer T401261U Atlas 360 Positioner Titan Stabilizer T401244 StableSoft II Stabilizer Atlas Positioner Atlas Positioner Attachment 9930/25 T401270 Suture Holder Insert 9945/25 Atlas 360 Positioner Titan Stabilizer Attachment, Long Shaft StableSoft II Stabilizer Titan 360 Stabilizer Attachment Suture Holder Insert Atlas 360 Positioner Attachment Titan Stabilizer - Long Shaft Attachment StableSoft II Stabilizer - Long Shaft Titan Flex Stabilizer Titan Flex 360 Stabilizer StableSoft Ultra Stabilizer OPVAC Synergy Ultra Transducer Cover Rapid-i Kit Percutaneous Insertion Kits HLS Cannulae, non coated, with BIOLINE or SOFTLINE Coating "HLS Cannulae, non coated, with BIOLINE or SOFTLINE Coating QUADROX-i Adult with filter and with BIOLINE Coating QUADROX-iD Adult QUADROX-i Small Adult with BIOLINE Coating QUADROX-iD Adult with BIOLINE Coating QUADROX-i Adult QUADROX-i Adult with filter QUADROX-i Small Adult with filter QUADROX-i Small Adult QUADROX-i Adult with BIOLINE Coating QUADROX-i Small Adult with filter and with BIOLINE Coating EVA NEXUS Ophthalmic surgical system ROTAFLOW Centrifugal Pump Scleral Buckling Products Tray, Surgical Instrument PERI-LOC FORCEPS TRAY 3.5MM DSTL TIB CALC LK PL TRAY PERI-LOC CLAVICLE INST & IMPL TRAY CADDY {} SM PLATES {} BASIC PERI-LOC 2.7MM DR GD CADDY PERI-LOC VLP INSTRUMENT TRAY LID VLP FOOT COMPACT TRAY PERI-LOC 6.5MM SCREW/INSTRUMENT TRAY LID CADDY {} MINI INSTRUMENT PERI-LOC 6.5 CANC SCREW CADDY PROXIMAL FEMUR TARGETER OUTER TRAY LID Single Use Magnetic Transfer Zone 16" x 10" - Private Label NOVAPLUS 200-16B-V PROXIMAL FEMUR IMPLANT TRAY LID STER CASE-RINGS 80-130MM CADDY {} SM INSTS {} BASIC PERI-LOC VLP DIST TIB/FIB LOCK PL TRAY PERI-LOC VLP INSTRUMENT TRAY PERI-LOC CLAVICLE INST & IMPL TRAY LID VLP FOOT 3.5MM/5MM IMPLANT TRAY LID WIRE CADDY JET-X IMPLANT TRAY PERI-LOC SM FRAG SCREW CADDY PERI-LOC VLP AUXILIARY SCREW CADDY 4.5MM L-D FEMUR LK PL TRAY PERI-LOC SM FRG STR LCK PL CDY PERI 6.5MM CANC SCW CDY LD CABLE SADDLE AND LHI CADDY LID VLP 2.7MM/3.5MM BASE INSTRUMENT TRAY PERI-LOC PERI-ART FORCEPS TRAY LID 7MM SCREW CADDY LID LARGE FRAGMENT STRT PLT TRAY CADDY {} SM DRILLS PERI-LOC SM FRAG DRL GDE CADDY TRAY C {} PELVIC INSTS PERI-LOC VLP PROX TIB LOCK PL TRAY JETX 5MM XSHT HP INSRTN TRAY LID CADDY {} SM PLATES {} DELUXE LRG CANN SCR INSTR TRAY LID PROXIMAL FEMUR TARGETER INSTRUMENT TRAY STER CASE-RINGS {} 140-180MM VLP FOOT TEMPLATE TRAY SMALL CANN SCREW INSTRUMENT TRAY LID CADDY {} SM SCREWS {} BASIC HEX FIX COMPONENT TRAY PERI-LOC SM FRAG STR PL CADDY PERI-LOC 2.7MM SCREW CADDY LID RING CASE 155MM AND 180MM LID INSTRUMENT CASE LID VLP FOOT 2.7MM/4MM IMPLANT TRAY LID 4.5MM L-P TIB LK PLATES TRAY TRAY {} PELVIC INSTS VLP 2.7MM/3.5MM INSTRUMENT TRAY 6.5MM SCREW CADDY LID SMALL CANN SCREW CADDY LID TRAY B {} PELVIC INSTS 7MM CANN SCREW CADDY AESCULAP LID W/RETENTION PLATE SILVER AUXILLARY INSTRU MODULE STER CASE W-LID 3.5MM L-P TIB TGR TRAY 8MM CANN SCREW CADDY CADDY {} MINI PLATE CADDY {} MINI SCREWS LID {} CADDY {} MINI PLATES VLP FOOT IMPLANT TRAY VLP FOOT COMPACT TRAY LID PERILOC SM FRAG SCREW CDY LID PERI-LOC CLAVICLE PL CADDY LID Scalpel Holder LONG CANNULATED SCREW CADDY PERI-LOC VLP SCREW CADDY LID PERI-LOC SM FRAG BASIC INST TRAY LID TSF RINGS STER.TRAY Sharps Saf-T Zone w/o tray CADDY {} MINI DRILLS PERI-LOC PERI-ART FORCEPS TRAY 8MM SCREW CADDY LID WIRE CAP LID CADDY {} LG SCREWS PERI-LOC 4.5 S-T CRTX SCR CDY PERI-LOC 2.7MM INST & SCR TRAY TRAY LID FOR LRG CANN SCREW VLP 2.7mm/3.5mm INST TRAY LID STERILIZATION CASE-RINGS {} 200MM-240MM PERI-LOC SM FRG INST TRAY SPCR STER CASE-RODS {} POSTS Single Use Magnetic Transfer Zone 3" x 4 1/2" Sharps Saf-T Transfer Drape Non-Magnetic 32/case REF TR ACET LINR TRAY INS FRAME STABILIZER CASE VLP 2.7mm/3.5mm BASE INSTRUMENT TRAY LID PROXIMAL FEMUR TARGETER OUTER TRAY TRAY {} LG FORCEPS PERI-LOC VOL DST RAD TRY LID STER CASE-WIRES {} INST PERI-LOC 6.5 CANC SCR CDY LID 6.5MM CANN SCREW CADDY VLP FOOT IMPLANT TRAY LID SMALL CANN SCREW CADDY PL 3.5 STR LCK/NOLCK PL CDY LD PROXIMAL FEMUR IMPLANT TRAY Single Use Magnetic Transfer Zone 3" x 4.5" - Private Label Cardinal Health 100-10B STERIL TRAY F/SPAT FRAME STRUTS/WREN PERI-LOC 4.5 S-T COR SC CDY LD VLP 2.7MM/4MM IMPLANT TRAY 3.5MM L-P TIB LK PLT TRAY EUROPEAN PROX FEM INSTR TRAY JETX CENTRAL TR INSTR CASE PERI-LOC VDR SCRW CADDY LID CADDY {} SM INSTS {} DELUXE LID INSERT F/TSF ASSEMBLY WIRE CAP TRAY PERI 4.5MM CRTX SCRW CADY LD 3 HEADLESS/2 QFX SCREW CADDY DROP-IN PERI-LOC SM FRG SCREW CDY LID PERI-LOC SM FRG INS TRAY REV 1 VLP FOOT TEMPLATE TRAY LID RING CASE 130MM AND 205MM LID LARGE - UNI EXT FIX SYS INNER TRAY LID TRAY {} BLADE PLATES Single Use Magnetic Transfer Zone 16" x 20" -Private Label Cardinal Health 200-20B Single Use Magnetic Transfer Zone 16" x 10" Single Use Magnetic Transfer Zone 16" x 20" PERI-LOC LG FRG INS TRAY REV 1 REF TRIAL ACET SHELL TRAY 4.5MM L-D FMR TRGTR TRAY TRAY {} LG PLATES JETX HALF PIN INSERTION TRAY VLP 2.7mm/3.5mm ANCILLARY INST TRAY LID SM FRAG PLATE CADDY {} CP/PF PERI-LOC VLP SCREW CADDY PERI-LOC VLP PROX TIB LOCK PL TRAY LID HALF PIN MODULE STER CASE WITH LID CADDY {} SM PLATES {} DELUXE Single Use Magnetic Transfer Zone w/Tray 16" x 20" PERI 5.7MM CAN LCK SCW CDY LD PERI-LOC 4.5 S-T LK SCR CDY LD PERI-LOC VLP DRILL CADDY STER CASE-NUTS {} BOLTS PERI-LOC 4.5 S-T LCK SCR CADDY TRAY {} LG INSTRUMENTS PERI-LOC 5.7 CAN SCREW CDY LID TRAY A {} PELVIC RED INSTS AESCULAP BOTTOM CONT PERFORAT 135MM Single Use Magnetic Transfer Zone 16" x 10" - Private Label Leonhard Lang ST-12 P-L 2.7MM DRL GD CDY LD WIRE CADDY LID LONG CANN. SCREW CADDY LID JET-X 6MM HALF PIN INSERT TRAY VLP 3.5MM/5MM IMPLANT TRAY PERI-LOC ELBOW LCK PL TRY PERI-LOC LG FRAG SCREW TRAY PERI-LOC CLAVICLE PLATE CADDY PERI-LOC SM FRAG INST TRAY RING CASE 130MM AND 205MM Single Use Magnetic Transfer Zone w/ Tray 16" x 10" STER CASE-TELESCOPIC RODS PERI-LOC VOL DIST RAD TRY HARDWARE CASE LID LG - UNI EX FIX SYS OUT TRAY - TALL TRAY PERI-LOC 2.7MM INSTR&SCREW TRY LID {} CADDY {} SM SCREWS LRG CANN SCR INSTR TRAY FULL TRAY FOR LRG CANN SCRW SMALL CANN SCREW SYSTEM TRAY PERI-LOC VLP IMPLANT TRAY LID LID {} CADDY {} MINI SCREWS PERI-LOC VLP DIST TIB/FIB LK PL TRAY LID MAYO STAND CADDY LG FRAG PLATE TRAY {} CP/PF Single Use Non-Magnetic Zone 16" x 10" Single Use Magnetic Transfer Zone 16" x 10" - Private Label Cardinal Health 200-16B INSTRUMENT CASE OPTIONAL INSTRUMENT TRAY PERI-LOC VLP AUXILIARY SCREW CADDY LID 2.5/3 CANN SCREW CADDY DROP-IN SPATIAL FRAME HARDWARE CASE 4.5MM LP TIB TRGTR TRAY STERILIZATION TRAY DRS LG FRAG PLATE TRAY {} PF PERILOC 3.5MM STRT PL CDY LID CABLE SADDLE/HOLE FILLER CADDY PERI-LOC SM FRAG BASIC INST TRAY PERI-LOC 6.5MM SCREW/INSTRUMENT TRAY CHISEL BLADE RADIAL 13X120X1MM - 18S JET-X CENTRAL TRAUMA IMPL CASE PERI-LOC SM FRG STR LK PLT LID PERI-LOC LG FRAG SCREW CADDY TRAY {} PELVIC IMPLANTS PERI-LOCK 5.7 CANN LCK SCR CDY STER CASE-PLATES HEX FIX HALF PIN TRAY PERI-LOC 2.7MM LCK SCREW CADDY SMALL CANN SCREW INSTRUMENT INNER TRAY SMALL CANN SCREW SYSTEM LID 3.5MM D TIB TGTR TRAY RING CASE 155MM AND 180MM JETX MINI TRAY PERI-LOC VOL DST RAD SCRW CDDY AESCULAP BOTTOM CONT PERFORAT 90MM PIN, BLUNT, 2.4MM TSF PIN/WIRE STER TRAY CADDY F/TSF BOLTS {} WASHERS VLP 2.7MM/3.5MM ANCILLARY INST TRAY CADDY {} SM SCREWS {} DELUXE EUROPEAN PROX FEM INSTR TRAY LID SMALL CANN SCREW INSTRUMENT TRAY PERI-LOC VLP IMPLANT TRAY PERI-LOC SHLDR LCK PL TRY PERI-LOC SM FRAG DRILL CADDY LG - UNI EXT FIX SYS OUT TRAY - SH TRAY PERI-LOC 4.5MM LCK SCRW CDY LD NEEDLE COUNTER 80710CARD- Single Use Magnetic Transfer Zone 16" x 10" - Private Label Cardinal Health 200-16B 80730CARD- Single Use Magnetic Transfer Zone 3" x 4.5" - Private Label Cardinal Health 100-10B 80710- Single Use Magnetic Transfer Zone 16" x 10" 80720- Single Use Magnetic Transfer Zone 16" x 20" 80720CARD- Single Use Magnetic Transfer Zone 16" x 20" -Private Label Cardinal Health 200-20B DMEK Surgical Disposable Set 1508/25 SCCW01/20 KL701W/20 KL006/12 KL004/20 OR004/20 KL005W/20 KL001W/80 KL001/80 KP1826/25 KP2226/20 KP11829/50 1341/25 CFD024/20 KL002/40 19400/25 KLF200/20 KL703W/20 KL002W/40 KP11826/20 1528/25 KL004W/40 1648/25 0008 KL006/20 19405/50 1538/25 KL003/40 KL016W/10 1528W/10 1518/25 KL702W/20 PFD019/50 KL005/20 KL030W/03 1265/25 PHS 489150 KP1319F/50 KLF100/20 Robotic Arm Drape Halyard Drape ORS Drape Camera Drape Microtek Versisus Drape Drape, Surgical Versius Equipment Drapes Probe Covers Drape and Calibration target for use with ActivSight imaging system CoreVista® Monitor Drape Halyard Basics Drape Corin Camera drape Tablet Drape QUADROX-i Microporous Membrane Oxygenator w and w/o Arterial Filter with holding clamp EXCOR Pediatric PiCCO Catheter ROTAFLOW Centrifugal Pump with SOFTLINE Coating

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	2018-05-14
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2013-02-12
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
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2024-02-07
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2024-02-07
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2024-02-07
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2024-02-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-02-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-02-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-02-07
FXY	Hood, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-10
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-04-20
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-04-20
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2013-02-11
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2013-02-11
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2017-11-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2012-10-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-19
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
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2015-01-11
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2014-02-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2013-02-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-09-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-07-15
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-07-15
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-06-30
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2012-11-12
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2024-02-07
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2017-03-22
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-02-08
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2019-01-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-07-29
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2025-07-29
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2025-07-29
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2025-07-29
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2013-02-12
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2025-07-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-12-19
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-11-15
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-03-02
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2015-01-11
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2015-01-11
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2015-01-11
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-02-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-02-07
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2024-02-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-15
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2024-02-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-11
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2024-02-07
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2013-02-11

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
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.

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3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807090. Last updated year: 2026. Please use registration number 3002807090 when referencing this establishment in official correspondence.