Sterigenics SAS

FDA Device Registration & Listing · Rantigny Oise, FR · Registration 3007156625

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007156625
FEI Number
3008133910
Entity Name
Sterigenics SAS
City/State/Country
Rantigny Oise, FR
Establishment Address
8 Rue Parmentier, Rantigny Oise 60290, FR
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Subdural Drainage Catheter Kit Parietex™ ProGrip™ DORMIA Fertiloscopy F42K Kit FH 1.29 / FTO 1.40. Intracranial Pressure Monitoring Cup Catheter (ICP) Celsite® Discreet STL201H Integra Flow Regulating Valves Low Flow Integra Flow Regulating Valves Low Flow Mini Integra OSV II Valve Units OSV ll Valve SYstem 2 PIECE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH ANTECHAMBER AND INTEGRAL 7 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve System 3 PIECES SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve System with antechamber and separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem BURR HOLE SYSTEM FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem 3 PIECE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Lumbar Valve System FLOW REGULATION* : 18 - 30 ml/hr WITH SEPARATE 80 CM LUMBAR CATHETER OSV ll Valve SYstem FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve Unit WITH 2 INTEGRAL CONNECTORS FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System with separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH ANTECHAMBER AND INTEGRAL 13CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH ANTECHAMBER AND INTEGRAL 9 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH INTEGRAL 9CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System 3 PIECES SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem BURR HOLE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve Unit WITH ANTECHAMBER AND 2 INTEGRAL CONNECTORS FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH INTEGRAL 7 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr lntegra Flow Regulating Valve Low Flow Std FLOW REG : 8 - 17 MI/hr 3 PIECES SYSTEM WITH ANTECHAMBER Parietex™ Folysil Silicone Foley Catheter Re-Trace Ureteral Access Sheath L22&55cm Integral Drainage Set Integral Lumbar Drainage Set Integral Ventricular Drainage Set Kolibri Direct Puncture Sets Kolibri Percutaneous Nephrostomy Catheters Kolibri Percutaneous Nephrostomy Kits CSF Reservoir Celsite Babyport (REF 05433742) / Celsite Babyport S (REF 05433842) Slotted Catheter Reservoir 4cm Phoenix Slotted Right Angle ca Slotted Catheter Reservoir 8cm Neonatal Reservoir - 7cm Anti-Block Catheter 12cm Scope Anti-Block Catheter 7cm Scopea Endoscopic right angle, Anti-Blok ventricular catheter with reservoir, 3 cm Anti-Block Catheter 8cm Scopea Phoenix Slotted Catheter Slotted Right Angle Catheter 9 Neonatal Reservoir - 6cm Slotted Catheter Reservoir 9cm Anti-Block Catheter 10cm Scope Anti-Block Catheter 6cm Scopea Slotted Right Angle Catheter 5 Anti-Block Catheter 4cm Scopea Neonatal Catheter Reservoir 4c Phoenix Slotted Cathter Reserv Anti-Block Catheter 11cm Scope Neonatal catheter reservoir 3c Slotted Right Angle Catheter 6 Neonatal Reservoir - 5cm Slotted Catheter Reservoir 6cm Slotted Catheter Reservoir 10c Slotted Catheter Reservoir 12c Anti-Block Catheter 9cm Scopea Slotted right angle catheter 7 Slotted Catheter Reservoir 7cm Anti-Block Catheter 5cm Scopea Slotted Catheter Reservoir 11c Slotted Right Angle Catheter 8 Auragen Cortical electrode Auragen Cortical surface electrodes OSYHAND LIPO Tubular Sheath Catheter Passer Re-Trace Ureteral Access Sheath Ureteric catheters RUP Right Angle Guide Smoothkit SMOOTHKIT+ Celsite (REF 05433734) Polypropylene Burr-hole Reservoirs and Cap Re-Trace Ureteral Access Sheath Infusion Catheter 30cm with Mo Infusor Infusion Tubing VenaTech LGM 30D/U Vortek Double Loop Ureteral stents Parietene Macroporous Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 7 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 6 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 5 cm Perf (Ommaya Style) Reservoir Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 12 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 11 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 3 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 10 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 9 cm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 4 cm Perf (Ommaya Style) Reservoir, bottom-inlet, 19 mm Perf. Unitized Catheter Reservoir, Large Cap, Anti-blok ventricular catheter, 8 cm Pressio® Parenchymal Bolt Intracranial Pressure Monitoring Kit Pressio® Parenchymal Tunneling Intracranial Pressure Monitoring Kit Pressio® disposable hand drill Ventricular Tunneling ICP Monitoring Pressio® Kit CABSAIR® PEDIGUARD PediGuard TriTip 2.5 XS PediGuard XS PediGuard Tri-Tip 3.2 PediGuard Tri-Tip 4 PediGuard Curv PediGuard Curv XS PediGuard Cannulated Handle PCN and Ureteral Dilators Magic Catheter Integra Ventricular Catheters with radiopaque dots Kubula External Drainage Catheter Integra DP Valve System Integra DP Valve Systems, stainless steel connectors, burr hole reservoirs and caps Ventricular, atrial and peritoneal catheters Subcutaneous Tube Passer Connector PTFE-coated Seldinger guidewire PCN guidewires Soprano® PTFE-Nitinol Guidewire BIOMESH® CA.B.S.' AIR® Composite Burr Hole Valve and Shunt System PEDIGUARD DSG Pin Total Abscession Nephrostomy Drainage Catheter GP General Purpose Drainage Catheter Aspiration and Flush Assembly Skater Nephrostomy Drainage Catheter w/ Locking Pigtail Ulti-Flo General Purpose Drainage Catheter Nephro-Cath Nephrostomy Drainage Catheter ReSove CirQ Nephrostomy Catheter PCN Needles Omnishunt Valve System Gravity Compensating Accessory Integra DP Valve Systems, stainless steel connectors, burr hole reservoirs and caps DSG Pin 6 DSG Pin 1 DSG Pin 5 ARIS 4DDOME® Disposable Catheter Passer 30c Disposable Catheter Passer 65c Disposable Catheter Passer 45c Celsite (REF 05430095, 05430425, 05432460, 05433556, 05433750, 05433823, 05436709, 05436717, 05436725, 05436946) Celsite Discreet (REF 05430144, 05430145, 05430146) NovoFlow Reinforced Ureteral Stent External Drainage Set Lumbar drainage sets and accessories Tuohy needles Lumbar Catheter Accessory Kit Complete ICP Monitoring and Drainage Set 14G TUOHY NEEDLE Equi-Flow Valve and Shunt Systems Right Angle Step Connector Neonatal straight connector "Y" Connector Straight Connector 5/pack "T" Connector POWERPULSE HIP/KNEE DISP UNT W/SUCT POWERPLSE HIP/KNEE DISP UNT W/O SUC 0210-166-000 0210-210-000 0210-010-100S1 0211-110-000 0210-015-000 0210-218-000 0210-010-100 0210-918-100 0210-114-100 0210-918-000 0210-018-200 0211-100-000 0210-167-000 0210-218-100 0210-118-100 0211-214-000 0210-018-100 0210-018-000 0210-012-000 0211-118-000 0210-165-000 0210-114-100S1 0210-014-000 0210-200-000 0210-114-000S5 0210-212-000 0210-100-000 0211-112-000 0210-158-000 0210-118-200 0210-100-000S4 0210-110-000 0210-016-000 0210-112-000 0210-014-100 0211-212-000 0210-114-000 0210-058-000 0210-900-000 0210-214-000 0211-114-000 0210-010-000 0210-110-100 0210-118-000 0210-014-600 ELEFANT Bio Med wash Drainage Accessory Kit Silicone Double Loop Ureteral Stent Stent, Ureteral Silicone Double Loop Ureteral Stent Jackson-Pratt Wound Drainage Devices TRU-CLOSE Suction Drainage System Suction Reservoir Kit Celsite (REF 05433734) Celsite (REF 05430095, 05430425, 05432460, 05433556, 05433750, 05433823, 05436709, 05436717, 05436725, 05436946) Celsite Babyport (REF 05433742) / Celsite Babyport S (REF 05433842) Celsite Concept (REF 05437025, 05437026, 05437028) Celsite (REF 05430100, 05430101) Celsite Discreet (REF 05430144, 05430145, 05430146) SimpleCAP™ X-TIP Biopsy Needles M-Biopsy™ Needle For Reusable Biopsy Instruments Bone Marrow Biopsy and Aspiration Needles Double Diamond "J" and "I" Type Bone Marrow Needle HV Lumbar Valve Systems and accessories HV Lumbar Valve Systems and Stainless Steel F5/ F8 Stepdown Connectors Rickham Type Reservoir Polysul Venatech LP Brachial Introducer System (Antecubital) (REF 04439985) PediGuard DSG Connect 3.2 PediGuard DSG Connect 4 PediGuard DSG Connect 2.5 XS PediGuard DSG Connect Curv Xs PediGuard DSG Connect Curv PediGuard DSG Connect 2.5 DSG Connect Handle DSG Starter Pin Endoscope and accessories Bone Needle for Bladder Injections Endoscope and accessories Bone Needle for Bladder Injections Celsite (REF 05430095, 05430425, 05432460, 05433556, 05433750, 05433823, 05436709, 05436717, 05436725, 05436946) Celsite Concept (REF 05437025, 05437026, 05437028) Celsite (REF 05430095, 05430425, 05432460, 05433556, 05433750, 05433823, 05436709, 05436717, 05436725, 05436946) Integra Auragen Depth electrodes Integra NPH Low Flow Valve PEDIGUARD Celsite (REF 05430100, 05430101) Cyst Puncture Catheter ProGrip™ Parietex™ In-line CSF Reservoir , Double Dome / Catheter Right Angle Ventricular Catheter Res. / Pectoral 4 cm Anti-reflux Peritoneal Catheter Right Angle Ventricular Catheter Res. / Pectoral 11 cm Peritoneal Catheter Polypropylene 3-way Connector Right Angle Ventricular Catheter 5 cm Anti-reflux Atrial Catheter Right Angle Ventricular Catheter Reservoir 5 cm Right Angle Ventricular Catheter 6 cm Paediatric Straight Ventricular Catheter 1.3 x 2.2 Right Angle Ventricular Catheter Res. / Pectoral 10 cm Right Angle Ventricular Catheter Res. / Pectoral 9 cm Right Angle Ventricular Catheter Reservoir 6 cm Titanium Symmetrical Connector Right Angle Ventricular Catheter Reservoir 8 cm Convertible CSF Reservoir, Flat Bottom Large Model / Catheter Convertible CSF Reservoir, Burr Hole Small Model / Catheter Right Angle Ventricular Catheter 4 cm Standard CSF Reservoir, Flat Bottom Large Model / Catheter Right Angle Ventricular Catheter 9 cm Right Angle Ventricular Catheter 7 cm Right Angle Ventricular Catheter Res. / Pectoral 8 cm Convertible CSF Reservoir, Flat Bottom Small Model / Catheter Right Angle Ventricular Catheter Reservoir 7 cm Standard CSF Reservoir, Burr Hole Large Model / Catheter Graduated Straight Ventricular Catheter 1.3 x 2.2 Standard Straight Ventricular Catheter 1.3 x 2.5 Right Angle Ventricular Catheter 8 cm Right Angle Ventricular Catheter Res. / Pectoral 12 cm Right Angle Ventricular Catheter Res. / Pectoral 7 cm Right Angle Ventricular Catheter Reservoir 11 cm Right Angle Ventricular Catheter Res. / Pectoral 3 cm Right Angle Ventricular Catheter Reservoir 9 cm Right Angle Ventricular Catheter Reservoir 4 cm Right Angle Ventricular Catheter Res. / Pectoral 5 cm Right Angle Ventricular Catheter Reservoir 12 cm In-line CSF Reservoir , Single Dome / Catheter Right Angle Ventricular Catheter Reservoir 3 cm Side-Inlet CSF Reservoir, Flat Bottom Large Model / Catheter Convertible CSF Reservoir, Burr Hole Large Model / Catheter Straight Ventricular Catheter 1.5 x 3 Side-Inlet CSF Reservoir, Flat Bottom Small Model / Catheter Titanium Asymmetrical Connector Right Angle Ventricular Catheter Res. / Pectoral 6 cm Integra OSVII Low Pro Valve Systems Integra OSV II Valve Systems OSV ll Low Pro Valve System with antechamber and separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH INTEGRAL 9CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve Unit WITH 2 INTEGRAL CONNECTORS FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH ANTECHAMBER AND INTEGRAL 9 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System with separate 15 cm ventricular catheter FLOW REGULATION* : 18 - 30 ml/hr lntegra Flow Regulating Valve Low Flow Std FLOW REG : 8 - 17 MI/hr 3 PIECES SYSTEM WITH ANTECHAMBER OSV ll Valve SYstem BURR HOLE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem 3 PIECE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve Unit WITH ANTECHAMBER AND 2 INTEGRAL CONNECTORS FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System WITH ANTECHAMBER AND INTEGRAL 13CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem FLOW REGULATION* : 18 - 30 ml/hr OSV ll Low Pro Valve System 3 PIECES SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem BURR HOLE SYSTEM FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem 2 PIECE SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Lumbar Valve System FLOW REGULATION* : 18 - 30 ml/hr WITH SEPARATE 80 CM LUMBAR CATHETER OSV ll Valve SYstem WITH INTEGRAL 7 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve SYstem WITH ANTECHAMBER AND INTEGRAL 7 CM VENTRICULAR CATHETER FLOW REGULATION* : 18 - 30 ml/hr OSV ll Valve System 3 PIECES SYSTEM WITH ANTECHAMBER FLOW REGULATION* : 18 - 30 ml/hr

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2016-03-31
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2019-01-24
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2017-08-21
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2017-08-21
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2017-08-21
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2013-06-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2013-07-15
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-08-21
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-01-15
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2017-07-20
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-01-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
LJE Catheter, Nephrostomy Unknown Class U N/A 2025-07-29
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2025-07-29
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular Neurology Class 2 882.5550 2013-06-27
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
GYC Electrode, Cortical Neurology Class 2 882.1310 2013-06-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-07-15
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2020-01-27
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-07-20
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2020-01-24
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-07-15
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-28
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-07-20
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2013-07-15
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2020-01-24
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-11-05
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2020-01-27
EJI Syringe, Cartridge Dental Class 2 872.6770 2012-12-04
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-07-15
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2017-08-21
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2019-01-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2013-07-15
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2020-01-24
OQL Mesh, Surgical, Deployment Balloon General, Plastic Surgery Class 2 878.3300 2013-07-15
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-07-15
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2017-08-21
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2012-12-28
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-08-21
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2026-05-12
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2026-05-12
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2017-08-21
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-07-15
GYK Instrument, Shunt System Implantation Neurology Class 1 882.4545 2020-01-27
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2025-07-29
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
FQH Lavage, Jet General Hospital Class 2 880.5475 2012-10-31
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-08-21
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2013-02-08
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2012-10-23
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
DZM Needle, Dental Dental Class 1 872.4730 2012-12-04
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2012-12-19
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-08-21
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2013-07-15
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2026-05-12
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2026-05-12
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-10-30
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2013-02-08
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
GYC Electrode, Cortical Neurology Class 2 882.1310 2013-06-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2017-08-21
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-06-25
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-01-15
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2020-01-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2013-06-27

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
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22
K936071 Smith & Nephew Dyonics, Inc. SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE 1994-08-19
K953574 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER 1995-09-29
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
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.

Similar Registrations

Registration Number Establishment Name Location
3015531529 Medtronic Neurosurgery Fort Worth, TX, US
3004593495 Plexus Manufacturing Sdn. Bhd. Bayan Lepas Pulau Pinang, MY
3014334038 Integra LifeSciences Production Corporation Mansfield, MA, US
3012507533 Integra Canada ULC Oakville Ontario, CA
3003418325 Integra LifeSciences Corporation Princeton, NJ, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007156625. Last updated year: 2026. Please use registration number 3007156625 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.