Sterigenics Radiation Technologies, LLC

FDA Device Registration & Listing · San Diego, CA, US · Registration 2024024

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
2024024
FEI Number
2024024
Entity Name
Sterigenics Radiation Technologies, LLC
City/State/Country
San Diego, CA, US
Establishment Address
7695 Formula Pl, San Diego, CA 92121, US
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

PROGENIX® PUTTY temporary carotid catheter for embolic capture ACCUNET, RX filler, bone void, calcium compound EVO3, OSTEOSURGE 300, TREL-XPRESS 300 ACCELL EVO3 TREL-XPRESS 300C TREL-XPRESS 300 OSTEOSURGE 300 Dexcom G6 Continuous Glucose Monitoring System Administration Sets and Accessories Macropore PS Protective Sheet Porous High Density Polyethylene Implant Synthes SynPor HD Polyethylene Three Dimensional Implants biologic material, dental Straumann Emdogain 0.3 ml, Multipack Administration Sets and Accessories Electrode, Cutaneous EMG Leads and Extensions EMG Leads and Extensions, (Model No. RS-ETL) Screws and plates Mystique Administration Sets and Accessories Provide® Protection Cap Administration Sets and Accessories Administration Sets and Accessories cleanser, root canal Straumann Pref Gel 0.6 ml wire, guide, catheter HT COMMAND PTA Guide Wire s (includes ES and FLOPPY sizes) wire, guide, catheter HT JET PTCA Guide Wire (Confidential) HT Command Guide Wire 14 Macropore NS Craniloc Foam Tip Plunger Foram Tip Plunger System wire, guide, catheter INTERMEDIATE 14 Guide Wire wire, guide, catheter STANDARD 14 Guide Wire PFA Therapy Cable PFA Therapy Cable Assy PulseSelect™ Pulsed Field Ablation Loop Catheter PulseSelect™ Pulsed Field Ablation Catheter Interface Cable Surgical Mesh, Polymeric PolyPro Mesh ACCELL EVO3C TREL-XPRESS 300C OSTEOSURGE 300C filler, bone void, calcium compound EVO3C, OSTEOSURGE 300C, TREL-XPRESS 300C Sensor, Glucose, Invasive Dexcom Coninuous Glucose Monitoring System catheter, percutaneous VIKING OPTIMA Guide Catheter Administration Sets and Accessories Electrode, Needle Interoperative Monitoring Disposable Stimulating Needle Electrode, Needle Protectrode® Disposable Monopolar EMG Needle Electrode, Needle Disposable Monopolar EMG Detachable Needle Electrode, Needle Disposable Monopolar EMG Needle Electrode Electrode, Needle DisposableEMG Ground / Reference Needle Disposable Monopolar EMG Needle Electrode, (Model Nos. DTM-10F, 10SAF, 1.50SAF, 1.75SAF, 20SAF, 30SAF, 60SAF - Interoperative Monitoring Disposable Stimulating Needle, (Model Nos. JO-5DSAF, JO-5DTSAF - GK-D50SAF, GK-D75SAF ) Disposable Monopolar EMG Detachable Needle, (Model Nos. DMD-25, 37, 50, 75) Disposable EMG Ground / Reference Needle, (Model No. GRD-SAF) Protectrode® Disposable Monopolar EMG Needle, (Model Nos. PRO-25F, PRO-25SAF, PRO-37SAF, PRO-50SAF) wire, guide, catheter PROGRESS Guide Wire Hi-Torque PROGRESS Guide Wire wire, guide, catheter REGISTA ARCHERY (Japan only, ¿confidential¿) Macropore PX Pediatric System Dexcom G6 Continuous Glucose Monitoring System PVAC GOLD MASC MAAC PulseSelect™ Pulsed Field Ablation (PFA) Loop Catheter PulseSelect™ Pulsed Field Ablation (PFA) Catheter Interface Cable Freezor MAX Cardiac Cryoablation Catheter catheter, biliary, diagnostic HERCULINK PLUS Biliary Stent System, RX catheter, biliary, diagnostic HERCULINK PLUS Peripheral Stent System, RX wire, guide, catheter BMW UNIVERSAL II wire, guide, catheter REGISTA CORSO (Japan only, ¿confidential¿) Administration Sets and Accessories Catherters and Accessories Graftgun Universal Graft Delivery System - Additional Graft Tube Graftgun Universal Graft Delivery System - Additional 5cc Grafgun Tube 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 Administration Sets and Accessories Dexcom G6 Glucose Program Continuous Glucose Monitoring System catheter, biliary, diagnostic ABSOLUTE 35 Peripheral Stent System (Confidential) catheter, biliary, diagnostic ABSOLUTE 35 Biliary Stent System wire, guide, catheter BALANCE MIDDLEWEIGHT 14 SurgiWrap Surgical mesh SurgiWrap MAST Bioresorbable Sheet Intracardiac patch Cardio-Wrap Biroresorbable Sheet PLEDGET CardioWrap Macropore Protective Sheet Macropore FX, PS, NS, LP Dexcom G6 Pro Continuous Glucose Monitoring System Versaturn Flex Versaturn Ultraflex Versaturn filler, bone void, calcium compound ORTHOBLAST II PUTTY & PASTE - NEXUS IC, ALLOFUSE, TREL-XC, OSTEOPORE, OSTEOSPARX C, ORTHOBLAST II PUTTY & PASTE -Nexus IC, Allofuse, TREL-XC PUTTY & PASTE, OSTEOSPARX C PUTTY & PASTE, Tranzgraft Blend AlloSync CB Putty & Paste TREL-XC PUTTY & PASTE OSTEOSPARX C PUTTY & PASTE ORTHOBLAST II PUTTY & PASTE Actifuse Shape (size 1-2mm/contents 1.6 mL) Actifuse Shape (size 1-2mm/contents 8 mL) Actifuse Shape (size 1-2mm/contents 15.8 mL) 506005078064-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 2.6 mL) Actifuse Shape (size 1-2mm/contents 2.6 mL) 506005078068-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 15.8 mL) 506005078062 -Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 1.6 mL) 506005078066-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 8 mL) Dressing, wound and burn, Hydrogel w/drug and/or biologic E-Z Derm NovaBone IRM SVF-2 Irrigation Tube Set Packs Moveable Suction Adapter Macropore OS Protective Sheet OMNILINK ELITE Peripheral Stent System OMNILINK ELITE Vascular Stent System (U.S.) stent, iliac OMNILINK ELITE Peripheral Stent System bone grafting material, human source DYNABLAST PUTTY & PASTE ACCELL CONNEXUS KEYSTONE DENTAL DYNABLAST PUTTY & PASTE filler, bone void, calcium compound ACCELL CONNEXUS, OSTEOSURGE 100, TREL-XPRESS 100 ACCELL CONNEXUS ACCELL CONNEXUS, Osteosurge 100, TREL-XPRESS 100 Osteosurge 100 TREL-XPRESS 100 Administration Sets and Accessories wire, guide, catheter FLEXI-WIRE wire, guide, catheter EXTRA S'PORT 14 Guide Wire coronary stent; ZETA J, OTW coronary stent; ULTRA, RX Stent System coronary stent; ZETA, RX Stent System coronary stent; ULTRA, OTW Stent System coronary stent; ZETA J, RX coronary stent; ZETA, OTW Stent System mesh, surgical Proformix Absorbable hemosatic agent and dressing Vitagel Surgical Hemostat Malleable Extended Applicator (MEA) Absorbable hemosatic agent and dressing Vitagel Surgical Hemostat CellPaker Collection Device catheter, biliary, diagnostic ABSOLUTE PRO 35 Biliary Stent System catheter, biliary, diagnostic ABSOLUTE PRO 35 Peripheral Stent System catheter, biliary, diagnostic ABSOLUTE PRO 35 LL Peripheral Stent System (Confidential) Dexcom G6 Pro Continuous Glucose Monitoring System XenMatrix Surgical Graft stent, carotid ACCULINK, RX wire, guide, catheter WIGGLE ArcScan Insight 100 ED3 EyeSeal HT Command Guide Wire 18 Foam Tip Plunger MICROSTAAR Injector - FTP Indigo HT JET PTCA Guide Wire Collagen Corneal Shields Administration Sets and Accessories SILCONE NASAL PARTS PRONG SM, MED, L, XL FOAM NASL CUSHIONS KNOSCUSHION MIXER, BREATHINF GASES,ANESTHESIA ARABELLA GENERATOR SET catheter, percutaneous; catheter, angioplasty, peripheral, transluminal AGILTRAC 35 Peripheral Dilatation Catheter Intracardiac patch MacroPore Cardio-Wrap (TS) CardioWrap Fiber, Medical, Absorbant Medical Cotton Ball 3144/24 8423/50 3264/24 3164/24 B PLDL 1000 R00201 AC {APCS COTTON BALL LAR 2/1000} 4250/50 4232/32 8462/50 B FMDLS 0130 R03606 TC {TOPCARE STER CB MED 36/130} B FMDLS 0500 R01201 US {USC BL M COT STER 12/500 USC S} 8461/50 8418/50 B PMDL 2000 R00201 US {USC COTTON BALL MED 2/2000} 3124/24 8415/50 8102/50 8201/50 8418/20 MED3034/24 8103/50 8460W/10 8418W/20 8023/50 B FMDLS 0130 R02401 HM {HEALTH MART STER CB MED 24/130} B FMDLS 0130 R03606 TA {TGT STER CB 36/130 245-07-0577} 8009/50 8468/50 WTL2025/25 8401/05 3034K/24 8401WNPP/05 MED3224/24 8415/05 4255/50 B PJDL 1000 R00201 US {USC COTTON BALL LG 1000/2} MED3144/24 3064/24 8002/50 3134/24 3264W/24 8456/10 8401WH/05 MED3064/24 8021/50 MED3234/24 3564/20 3534/20 B FMDLS 0130 R02401 GD {GOODNEIGHBOR STE CB MED 24/130} 8401WN/05 8210/100 MED3024/24 B PXDL 0500 R00401 US {USC COT BALL EXTRA LARGE 4/500} 10110/100 8465W/10 10105/100 8422/20 3064W/24 MED3264/24 3024K/24 UMW002/50 3544/20 8101/100 B FMDLS 0130 R03601 WG {WALGREEN STERILE 36/130 340996} 17460/20 8441/50 8250/50 8105/100 MED3044/24 8408/20 3064/24S 8430/06 8420/20 8215/100 8428/20 8412/20 3234/24 8030W/05 8010/50 8205/100 UMW001/50 3244/24 8011/50 8468/20 10120/50 MED3244/24 8402/20 B FMDLS 0130 R03606 AHL {CAREONE STERILE CB MED 36/130} 3024/24 8014/50 8105U/50 3044W/24 8102/100 3034W/24 3064K/24 3524/20 8414/50 MED3124/24 8405/50 8416/20 8201/100 8406W/10 8205W/100 MED303424/24 8440W/10 8469/10 16063/20 MED3164/24 8305/100 8204/50 8453W/50 3224/24 8401W/05 8020/50 8203/100 3044/24 10205/100 B FMDLS 0130 R02406 FBB {FIRST AID 24/130 STER BALL MED} 8202/100 8436W/25 B FMDLS 0130 R02401 SM {SUNMARK STER CB MED 24/130} 4270/50 8013/50 8436W/20 B FMDLS 0130 R02406 LE {LEADER 24/130 STERILE BALL MED} 8470/10 8106/50 8022/50 8110/100 4260/25 17440/20 B PMDL 2000 R00201 FH {FISHER COT BALL MED 2/2000} B FMDLS 0130 R02401 PB {PUBLIX STER CB MED 24/130} 8404/20 3034/24 8429W/20 8413/50 3044K/24 wire, guide, catheter BALANCE HEAVYWEIGHT 14 PTC665 PREP-TITE® CAP 5MM PTC557 PREP-TITE® CAP 7MM PTC667 PREP-TITE® CAP 7MM PTC345 PREP-TITE® CAP 5MM PTC477 PREP-TITE® CAP 7MM PTC465 PREP-TITE® CAP 5MM PTC455 PREP-TITE® CAP 5MM PTC475 PREP-TITE® CAP 5MM PTC457 PREP-TITE® CAP 7MM PTC467 PREP-TITE® CAP 7MM PTC555 PREP-TITE® CAP 5MM PTC347 PREP-TITE® CAP 7MM Xience XPEDITION OTW Drug Eluting Stent System Xience XPEDITION RX Drug Eluting Stent System Xience Xpedition OTW LL Xience Alpine OTW Xience Xpedition RX SV Xience Xpedition OTW SV Xience Prime Xience Alpine RX XIENCE Sierra RX Xience Prime LL Xience Xpedition OTW Xience Xpedition RX LL Xience Xpedition RX wire, guide, catheter FLOPPY 18 wire, guide, catheter FLOPPY II 14 EXTRA SUPPORT Administration Sets and Accessories Administration Sets and Accessories Vasculon Plus Catheter, intravascular, therapeutic, short-term less than 30 days NovaBone MacroFORM Administration Sets and Accessories mesh, surgical XenMatrix, DermMatrix Porcine surgical mesh; dermal matrix Xen Matrix Surgical Graft Bioresorbable bone fixation device Telamon, Cornerstone, Mesh SurgiWrap FROST Administration Sets and Accessories Electrode, Needle Disposable EEG Intraoperative Needle Electrode, Needle Disposable EEG Subdermal Needle Electrode Disposable EEG Subdermal Needle Electrode, OBM00046, DEN-12SAF - PRO-E12SAF - PRO-E3, EBLUE, EG, ER, EY, EBW, ERY. EE6X Disposable EEG Intraoperative Needle, (Model Nos. SDN1248, SDN1280, SDN1248B) Beaver Disposable Microsurgical Knives Xstar Eagle Labs - Eagle Gold Knife, Ophthalmic iAccess Precision Blade Alcon Cutting Instruments Administration Sets and Accessories bone grafting material, human source DYNAGRAFT D PUTTY & GEL DYNAGRAFT D PUTTY & GEL FASTResponder™ Sternal Intraosseous Device OsteoBallast Ballast Hi-Torque WHISPER 14 Guide Wire wire, guide, catheter WHISPER, EXTRA SUPPORT Guide Wire wire, guide, catheter WHISPER 14 Guide Wire wire, guide, catheter REGISTA CLEMENT (Japan only, ¿confidential¿) CAR-10-US, Cartiva Synthetic Cartilage Implant - US CAR-08-US, Cartiva Synthetic Cartilage Implant - US 90 Degree Breakaway Nozzle INTRODIGITATOR CDrive Cement Dispenser CDrive Cartridge Assembly KYPHON® Directional Bone Filler Device JET-VAC CEM DISP INT TIP KYPHON® Cement Delivery System Kyphon Bone Filler Device Kyphon Cement Delivery System Kyphon Bone Filler Devices FEMORAL PRESSURIZER Cement dispenser KYPHON® Bone Filler Devices HiVac Syringe Bone Cement Mixing and Delivery System MiniMix Delivery Syringe SMDS1C ZIMMER BONE CEMENT INJECTOR ZIMMER CEMENT DISPENS Hi-Torque Balance Middleweight UNIVERSAL wire, guide, catheter BMW UNIVERSAL biologic material, dental Straumann Emdogain 0.7 ml, Multipack Administration Sets and Accessories PROGENIX® PUTTY filler, bone void, calcium compound DYNAGRAFT II PUTTY & GEL - ALLOFUSE, NEXUS, ALPHAGRAFT, TREL-X, OSTEOSPARX, TRANZGRA DYNAGRAFT II PUTTY & GEL -Allofuse, Nexus OSTEOSPARX PUTTY & GEL DYNAGRAFT II PUTTY & GEL -Allofuse, Nexus, TREL-X PUTTY & GEL, OSTEOSPARX PUTTY & GEL, Tranzgraft AlloSync Putty & Gel TREL-X PUTTY & GEL Administration Sets and Accessories Administration Sets and Accessories adaptor, stopcock, manifold, fitting, cardiopulmonary bypass COPILOT Bleedback Control Valve COPILOT Bleedback Control Valve Priority Pack 20/30 Indeflator with CoPilot Bleedback Control Valve wire, guide, catheter BALANCE 14 Hi-Torque Balance 14 Guide Wires Administration Sets and Accessories Achieve Cable (990066) catheter, electrode recording, or probe, electrode recording ACHIEVE 990063 (15, 20) catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation Achieve Cable (990066) HD Mesh Mapper Catheter Orbiter ST & Conforma Diagnostic Electrode Catheters Woven Bipolar, Woven Tripolar, Woven Quadpolar, Woven Pentapolar, Woven Hexapolar, Woven Decapolar, Woven Open Lumen Qua 990063-015 Achieve Mapping Catheter 990063-020 Achieve Mapping Catheter AQUACEL Foam Super absorbent woven Eclypse Adherent Sacral Foam/silicone Advazorb Silflo/Silflo Lite Foam/silicone Advazorb/Advazorb Lite (Advazorb Plus) Super absorbent woven dressing Eclypse Boot Woven Eclypse Woven Ecylpse Adherent Mepore Pro / Ultra Foam/silicone Advazorb Silfix/Silfix Lite Non woven ribbon dressing Advadraw Spiral Non woven dressing Advadraw Dressing, Wound Hydrophilie Triad Foam Wound Dressings - 004766,004781,004782,003900, 003901,003902,003903,003904, 001502,001042, 005085 Zetuvit (plus) Advazorb Fixation Advadraw Zorflex ZF20 Zorflex ZF10 Eclypse Contour Zetuvit Plus Silicone (Border) Advazorb Heel Eclypse Adherent Advazorb Sacral Zorflex ZF15 Advazorb Areola Advadraw Spiral Advazorb Eclypse Foot Advazorb Silfix Eclypse Boot Eclypse Border & Border Oval Advazorb Border Lite Eclypse Advazorb Border Eclypse Adherent Sacral ConvaFoam Border ConvaFoam Non-Adhesive AQUACEL Foam Pro ConvaFoam Silicone Exufiber Connecta (Singles & Standalones) Stopcock, I.V. Set Connecta (Short Extensions) Stopcock, I.V. Set Connecta (Long Extensions) Stopcock, I.V. Set Connecta (Micro) Stopcock, I.V. Set catheter, biliary, diagnostic OMNILINK 18 Peripheral Stent System catheter, biliary, diagnostic OMNILINK 18 Biliary Stent System wire, guide, catheter HT WINN Guide Wire Absorb GT1 Bioresorbable Scaffold System Absorb Bioresorbable Vascular Scaffold System catheter, biliary, diagnostic OMNILINK 35 Peripheral Stent System catheter, biliary, diagnostic OMNILINK 35 Biliary Stent System Edwards Commander Delivery System Edwards Alterra Adaptive Prestent System Edwards Crimper Edwards SAPIEN 3 Pulmonic Delivery System Dental Collagen Wound Dressing wire, guide, catheter STEELCORE 18 Guide Wire Administration Sets and Accessories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NUN Bone Grafting Material, Human Source Dental Class 2 872.3930 2020-07-30
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2013-03-21
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-11-30
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2012-11-30
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2024-10-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-25
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction General, Plastic Surgery Class 2 878.3500 2012-11-30
NQA Biologic Material, Dental Dental Class 3 872.3930 2012-11-29
FPK Tubing, Fluid Delivery General Hospital Class 2 880.5440 2019-10-25
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2012-11-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-29
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2019-10-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-06-29
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2019-10-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-25
KJJ Cleanser, Root Canal Unknown Class U N/A 2012-11-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
GXR Cover, Burr Hole Neurology Class 2 882.5250 2013-02-25
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2013-02-25
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2012-11-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2024-02-09
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-11-30
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2012-11-30
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-11-30
MKY System, Skin Closure General, Plastic Surgery Class 1 878.4320 2019-12-06
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2012-11-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-25
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2019-10-25
GXZ Electrode, Needle Neurology Class 2 882.1350 2012-11-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
JEY Plate, Bone Dental Class 2 872.4760 2013-02-25
QDL Integrated Continuous Glucose Monitoring System For Professional Retrospective Use Clinical Chemistry Class 2 862.1355 2021-05-18
QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management Clinical Chemistry Class 2 862.1355 2021-05-18
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2021-05-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-10-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-08
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2015-10-07
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2019-10-25
FMF Syringe, Piston General Hospital Class 2 880.5860 2018-03-22
JRC Micro Pipette Clinical Chemistry Class 1 862.2050 2012-11-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-25
NYT Prosthesis, Tracheal, Expandable, Polymeric General, Plastic Surgery Class 2 878.3720 2024-10-21
QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management Clinical Chemistry Class 2 862.1355 2019-09-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-21
PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use General Hospital Class 1 880.5240 2018-03-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-21
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2012-11-29
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2012-11-29
JEY Plate, Bone Dental Class 2 872.4760 2013-02-25
JEY Plate, Bone Dental Class 2 872.4760 2013-02-25
QII Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use Clinical Chemistry Class 2 862.1355 2024-10-22
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2024-10-22
QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management Clinical Chemistry Class 2 862.1355 2024-10-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-07-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-11-30
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2012-11-30
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2012-10-24
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2012-11-29
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2017-12-06
MUU System, Suction, Lipoplasty General, Plastic Surgery Class 2 878.5040 2024-10-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2013-02-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-25
NIO Stent, Iliac Unknown Class 3 N/A 2013-03-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2019-11-18
NUN Bone Grafting Material, Human Source Dental Class 2 872.3930 2012-11-30
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-11-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
MAF Stent, Coronary Unknown Class 3 N/A 2013-03-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-08
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2012-11-29
LMF Agent, Absorbable Hemostatic, Collagen Based General, Plastic Surgery Class 3 878.4490 2012-11-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-21
QII Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use Clinical Chemistry Class 2 862.1355 2021-05-18
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2024-10-22
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2024-10-22
OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia General, Plastic Surgery Class 2 878.3300 2024-10-22
NIM Stent, Carotid Unknown Class 3 N/A 2013-03-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-25
FRO Dressing, Wound, Drug Unknown Class U N/A 2019-11-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-03-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-07-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-07-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-07-05
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2013-03-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-07-05
MOE Collagen Corneal Shield Ophthalmic Class 1 886.4750 2012-11-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-25
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2012-11-30
NIO Stent, Iliac Unknown Class 3 N/A 2017-07-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-21
OMH Pericardial Patch To Facilitate Revision Surgeries Cardiovascular Class 2 870.3470 2012-11-29
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2012-11-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-21
FRO Dressing, Wound, Drug Unknown Class U N/A 2021-05-13
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2012-11-30
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2013-01-13
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-04-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-10-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-04-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2019-10-25
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2012-11-30
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2017-12-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-08
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2019-10-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-10-21
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2012-11-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-11-29
EZX Mesh, Surgical, Metal General, Plastic Surgery Class 2 878.3300 2012-11-29
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2012-11-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-11-29
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-10-21
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2019-10-25
GXZ Electrode, Needle Neurology Class 2 882.1350 2012-11-30
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-08
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2019-10-25
NUN Bone Grafting Material, Human Source Dental Class 2 872.3930 2012-11-30
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2021-08-13
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2019-10-25
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-10-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
PNW Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant Unknown Class 3 N/A 2017-10-11
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2012-11-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-10-21
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2012-11-29
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2012-11-29
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2012-11-29
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2019-10-25
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2020-07-30
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2012-11-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2019-10-24
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2019-10-25
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2013-03-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-25
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2012-11-27
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2013-02-04
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2012-11-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
PNY Absorbable Coronary Drug-Eluting Stent Unknown Class 3 N/A 2016-07-07
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-22
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2023-01-27
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2017-12-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-10-25

Official Correspondent

Karen Whaley-Krumins

US Agent Details

No US Agent registered (Local establishment).

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
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024024. Last updated year: 2026. Please use registration number 2024024 when referencing this establishment in official correspondence.
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