Sterigenics Radiation Technologies IN, Inc

FDA Device Registration & Listing · Columbia City, IN, US · Registration 3009504230

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
3009504230
FEI Number
3009504230
Entity Name
Sterigenics Radiation Technologies IN, Inc
City/State/Country
Columbia City, IN, US
Establishment Address
4394 East Park 30 Drive, Columbia City, IN 46725, 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

Facet Fixx Hydrosil Rose Intermittent Silicone Catheters Magic3 Intermittent Silicone Catheters Hydrosil Discreet Intermittent Silicone Catheters Biodesign Staple Line Reinforcement Nexxt Matrixx Stand Alone Cervical System Blade INERTIA CONNEXX NEXXT MATRIXX STRUXXURE-A STRUXXURE-L Struxxure General Surgical Instrument ER2 Saturate Mixing System VORTEX & MIXOR NOZZLE UMBRELLA VORTEX ADAPTER VORTEX VACUUM MIXING SYSTEM VACUUM TUBE W/SUC BYPASS VORTEX & MIXOR NOZZLE ANGLED VORTEX VACUUM BOWL VORTEX&MIXOR NZLE STAND BRKAWY MIXOR FEMORAL PRESSURIZER-LG KYPHON® Mixer VORTEX RE-USE KIT VORTEX & MIXOR NOZZLE REVISION VORTEX&MIXOR NZLE LONG TAPERED 0206-548-000 0206-547-000 0206-556-000 0206-566-000 0206-545-000 0206-546-000 0206-509-000;0206-564-000 HiVac Bowl Bone Cement Mixing System B713 0506-482-000 0605-685-015 0606-573-000 0606-583-000 0306-564-000 0606-705-000 0506-689-015 0605-683-015 0606-595-000 0506-486-000 0606-509-000 MiniMix LV Bone Cement Mixing System SMLV 0605-687-015 0605-887-000 0506-685-015 0606-516-000 Medium Port MiniMix Bone Cement Mixing System SMMM1 RALLY Vacuum Mixing Bowl 7127-1801 0506-483-000 Mixing Bowl, Spatula B710 0606-593-000 0606-515-000 0606-517-000 0606-514-000 0707-001-000 AutoPlex M4 Cement Mixer 0506-489-000 0606-553-000S1 Kyphon Mixer 0606-705-000S1 0306-553-000S2 0506-485-000 0606-512-000 0606-593-000S1 0606-565-000 0506-686-015 0606-520-000 0506-683-015 0506-682-015 0606-518-000 0606-553-000 0606-563-000 0306-563-000 0306-573-000 0506-687-015 Magic3 GO Female Intermittent Silicone Catheters TrellOssTM-A Porous Ti Interbody System Matrixx SI Facet Fixx Struxxure Honour Inertia Spectris Solaris Qwik-Fit Syringe Spectris Solaris 96" low pressure connector tube with T-connector Spectris Solaris® Syringe Kit (SSQK 65/115vs) Spectris Solaris® Syringe Kit (SQK-65S) Spectris Solaris® Syringe Kit (SSQK-115) SSIT-96VLD Spectris Solaris® Syringe Kit (SQK-65VA) SIT-96V Spectra Solaris ® Tubing Set (SSIT-96VLD) MEDRAD® Dual Syringe Quad-Pak with a Large Saline Spike and a Small Contrast Spike(SDS-CTP-SCS) MEDRAD® Stellant Single Syringe Tri-Pak with QFT (SSS-CTP-QFT) MEDRAD® Stellant Single Syringe Tri-Pak with Spike (SSS-CTP-SPK) MEDRAD® Stellant Single Syringe with QFT (SSS-QFT) MEDRAD® Stellant Dual Syringe Quad-Pak with QFT (SDS-CTP-QFT) Stellant Single Syringe Tri-Pak with QFT Stellant Dual Quad-Pak with QFT Stellant Single Syringe Tri-Pak with Spike Stellant Dual Syringe Quad-Pak with Spike (Apollo) SDS-CTP-SPK LP-96-T-CV Low Pressure Connector Tube with T-Connector and Integral Check Valve Stellant Dual Syringe Quad-Pak with Spikes Stellant Single Syringe with Spike and Japan "T" Connector Stellant Single Syringe Tri-Pak with QFT (Apollo) SSS-CTP-QFT Stellant Single Syringe Tri-Pak with Spike (Apollo) SSS-CTP-SPK Stellant Single Syringe with Spike Stellant Single Syringe with QFT Stellant Single Syringe with Spike (Enhanced) SSS-SPK SSS-LP-60-T Low Pressure Connector Tube Set w/ T-connector 60" Stellant Dual Syringe Quad-Pak with a Large Saline Spke and a Small Contrast Spike Stellant Dual Syringe Quad-Pak with QFT (Apollo) SDS-CTP-QFT Stellant Single Syringe with QFT (Enhanced) SSS-QFT Stellant CT Syringe Kits (SJS-PT-J) Stellant CT Syringe Kits SJS-PT-J Stellant CT 96" Low Pressure Connector Tubing (LP-96-T-CV) MEDRAD® Stellant Single Syringe with Spike and Japan "T" Connector (SJS-PT-J) MEDRAD® Stellant Single Syringe with Spike (SSS-SPK) MEDRAD® Stellant 96" Low Pressure Connector Tubing Integral "T" with Check Valve (LP-96-T-CV) Saxxony MEDRAD® Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT MEDRAD® Mark V ProVis Sterile Disposable Syringe 150 mL & QFT (150-FT-Q) MEDRAD® Mark V ProVis 200 mL FasTurn Sterile Disposable Syringe & QFT (200-FT-Q) MEDRAD Mark V Provis 150mL FasTurn Sterile Disposable Syringe Kit MEDRAD Mark V Provis 200mL FasTurn Sterile Disposable Syringe Kit MEDRAD® Mark V ProVis Sterile Disposable Syringe 150 mL & QFT Orthopedic Manual Surgical Instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Carpal Tunnel Cutting Blade Suture Hook Disposable Cannula Argo Knotless TAPERED Broaching Punch, 4.75/5.5, Disposable Access Tool, Trocar Stylet Expectrum MVP Access Tool, Spacer Trinica Suture Retriever Carpal Tunnel Blade 5 Pack Parasmillie CONCEPT Shuttle Relay Access Tool, Blunt Cannulated Stylet Ankle Distractor Strap ICMC Sizing Trial Ceterix Disposable Suture Passer Trinica - Anterior Lumbar Plate Sys XIA PRECISION (48237105, 48237110, 48237115, 48237135) PERI-LOC TGR 4.5MM PF PIN 80MM 4.5MM TAP QC 2.7MM CANNULATED DRILL BIT - 155MM 2MM WIRE CAP 3.5MM PF PIN 18MM 3.5MM TGR TAP Q/QC 3.5MM GRAD BRAD PT DRILL GD ROD F/NAIL STR 4X900 KYPHON® EXPRESS™ Osteo Introducer® System 3.5MM SHORT DRL BIT W/QC SB HANDLE {} MINI BULB S/D {} QC 3.5MM SHORT DRILL {} BIT W/QC COUNTERSINK GENESIS PIN AND DRILL SET 1.6MM WIRE CAP THIN OSTEO BLADE 8 X 5 2.5MM/3MM COUNTERSINK W/QC REPLACEMENT RUBBER KIT PERI-LOC 3.5MM PF PIN 18MM SHORT LARGE - PARTIAL HALF PIN - INSTRU MODULE 2MM GUIDE ROD X 900MM SMOOTH SEMIEXTENDED ENTRY TUBE 3.2MM TIP THREADED GD PIN 3.2 X 230MM DRILL TIP GUIDE PIN 2.4MM TAP W/AO QC 4.5 DRILL BIT {} QC 195/170 GUD PIN TIP THRD 3.2 X 358MMCC 3MMX900MM BALL TIP GUIDE ROD 2.7 DRILL BIT {} QC 100/75 N8TIVE ACL Disposables Kit 4.5MM X 90MM DRILL PERI-LOC VLP 2.7MM X 40MM PF PIN 2.5MM/3MM CLEANING BRUSH 3.5 DRILL BIT QC 110/85 PERI-LOC CABLE SADDLE SHORT PERI-LOC 4.5 PF PIN 80MM SHORT 4.5MM DRILL BIT W/QC TROCAR PIN {} 3.5MM X 240MM PILOT DRILL {} 3.2MM X 127MM PERI-LOC 3.5 PF PIN 18MM SHORT PED TWIST DRILL - 2MM 2NM TORQUE LIMITER 2.7MM SHORT DRILL BIT W/QC 3.5MM TAP QC 2.5 DRILL BIT {} 95MM GOLD NQC DRILL LG 5MM HALF PIN STERILE PERI-LOC 4.5 TGR PF PIN 80MM GNS TROCAR PIN 1/8 in. X {} 5in PERI-LOC 4.5MM PF PIN 80MM SHORT 2MM TAP W/AO QC 3.2MM LONG GRAD BRAD PT DRILL DRILL SH 5MM HALF PIN STERILE 3.5 DRILL BIT {} 95/80MM NQC 2MMX900MM BALL TIP GDE ROD SAW BLADE ATTACHMENT STRYKER 2.7 DRILL BIT {} 110/95MM NQC DRILL EX SH 5MM HALF PIN STERILE 1.5 DRILL BIT {} QC 110/85 6.5/8MM CANN COUNTERSINK RAD OSTEO BLADE SZ 10 RAD OSTEO BLADE SZ 14 2MM GRAD BALL TIP GD ROD THIN OSTEO BLADE 10 X 5 MCGLAMRY ELEVATOR REF TPR HOLE CVR INSERTER PERIOSTEAL ELEVATOR 6MM STR RT DRILL 3.5MM IMHS 3.5MM TWIST DRILL DRILL BIT (SHORT) 3.5MM PERI-LOC SCREW HOLE FILLER TWIST DRILL (2.7MM X216) 3.5MM PF PIN 40MM PILOT DRILL 3.2MM X 76MM TARGETER 3.5MM DRILL BIT W/QC MINI - UNI EXT FIXATOR SYSTEM TIPTHRD GDE PIN 3.2MM 385MM JET-X MINI DISTAL RADIUS HALF PIN DRIVER 3.5MM SHORT DRILL BIT W/QC THIN OSTEO BLADE 10 X 3 JETX DS/TROC F/5 & 6MM SHT HP 4MM LONG PILOT DRILL DRILL BIT 1.5 QC 85/60 1.5 DRILL BIT {} 95MM NQC 3.2MM X 358MM TGR DRILL BIT 2MM SHRT DRLL BIT W/QC 2MM DRILL 130MM PERI-LOC VLP 2.7MM X 14MM PF PIN 2.7MM PF PIN 18MM 4.5MM TGR TAP Q/QC 3.2MM SHORT GRAD BRAD PT DRILL 2.5 DRILL BIT {} QC 110/85 GOLD 3.2 DRILL BIT {} QC 195/170 3.2MM X 300MM THR GUIDE PIN TGR 3.5MM DRILL TIP PF PIN 18MM 2.7 DRILL BIT {} QC 125/100 4.5MM SHORT DRILL BIT W/QC LARGE - BAR MODULE 3.2 DRILL BIT {} QC 230/205 3F SAW BLADE ATTACHMENT AMSCO-HALL 7MM COMPRESSION SCREW DRILL 1.3MM CANN COUNTERSINK W/QC THIN OSTEO BLADE 12 X 3 THIN OSTEO BLADE 20 X 3 3.5 DRILL BIT {} QC 195/170 PERI-LOC TGR 3.5MM PF PIN 18MM BRAD-TIP DRILL BIT 4 X 180MM JOYSTICK THREADED PIN {} LARGE REVERSE VERBRUGGE {} 280MM RAD DRILL GUIDE REVISION NAIL 3.2 DRILL BIT {} QC 145/120 GD ROD F/NAIL STR 3X900 COMBINATION TOOL IMHS 3.2MM X353MM GDE PIN 3.5 DRILL BIT {} 180/165MM NQC TGR LG FRAG 4.5MM CAN DRL W/QC PERIOSTEAL ELEVATOR 2 DRILL BIT {} QC 125/100 3.2MM X 300MM GUIDE PIN STERILE 6.4MM DRILL 3.2MM X 300MM DRILL TIP GUIDE PIN TROCAR PIN {} 4MM X 240MM TRIGEN DISPOSABLE EXTRACTOR ROUTER {} QUICK COUPLING FEM/REC DR 4.8X 311MM 4.5 DRILL BIT {} QC 196/170 3F JOYSTICK THREADED PIN {} SMALL TROCAR PIN 3.5MM X 330MM TROCAR PIN {} 2.7MM X 216MM THIN OSTEO BLADE 8 X 3 2MM CANN DRILL BIT W/QC JET-X 4.8MM STEP DRILL -6MM HP STDRL 8 RECON PROX SCR 3.2 DRILL BIT {} 130/115MM NQC SMALL FRAG COUNTERSINK 2MM DRILL W/QC 2MM PF PIN 14MM 1.1MM WIRE CAP GUIDE PIN TRO PT 1.3 X140 GUIDE PIN TIP THRD 3.2 X 300MM 2.7MM DRILL W/QC DIAMOND POINT PIN {} 1.9MM HOHMANN RETRCT L ONG {} 15MM KYPHON® Osteo Introducer® System KYPHON® EXPRESS™ Advanced Osteo Introducer® Device 3.2MM TROCAR 2.7MM DRILL 191MM BOHRER 43 MM FUR COLE RONTGENDURCHL.WINK Esser Pelvic Guide REVERSE VERBRUGGE 190MM 2 DRILL BIT {} QC 100/75 2MM PF PIN 25MM REF ACET CUP POS/IMP TIP KYPHON® Osteo Introducer™ System SUPER SHUTTLE SUTURE PASSING SYSTEM, QTY 8 BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 18.5 IN , STERILE, 1.1 X 470MM (45 X 18.5IN) SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE LEFT, QTY 3 PERI-LOC 2.7MM DRILL GUIDE PF PIN 14MM 1.1 DRILL BIT {} 45MM NQC SHORT 3.5MM BRAD PT DRILL 4MM SHORT AO PILOT DRILL 1.1 DRILL BIT {} QC 60/35 4.5 DRILL BIT {} 130/115MM NQC 2.7MM SHORT DRL BIT W/QC SB FREER ELEVATOR Manos PERI-LOC SM FRAG INST & IMPLANT SET LID 2MM DRILL BIT W/ QC - 157MM BOHRER 38 MM FUR COLE RONTGENDURCHL.WINK 5MM SHORT PROTECTOR 6.5MM CANCELLOUS TAP QC RAD OSTEO BLADE SZ 12 PERIOSTEAL ELEVATOR-6MM CURVED THREADED TIP GUIDE PIN 3.5MM DRILL BIT W/QC SB GD RD F/RMR-SPADE 3.2X900 .2.5 DRILL BIT {} QC 230/205 3F JET-X {} DRILL SLEEVE-ST/XSHT HP 2.7MM STEPDRILL - SHORT DRILL LG 6MM HALF PIN STERILE CANN. DRILL F/HA PINS {} 4.8MM HYPERFLEX GUIDEWIRE, NITINOL, 9 IN, STERILE, 1.6 X 229MM (62 X 9IN) 6MM X 50MM DISPOSABLE CANNULA W/ OBTURATOR, THREADED, 6 EA Q-Fix Disposable Kits 3.5MM DRILL 130MM THIN OSTEO BLD ROUND END 12MM 3.2MM X 343MM BRAD POINT TIP GUIDE PIN DRILL 10 CM LONG TIP THR GDE PIN 2.4X305 THIN OSTEO BLD ROUND END 20MM EZ Pass 3.5MM X 90MM DRILL 3.2MM TIP THREADED GUIDE PIN STDRL ALL 6.4 REC PROX SC CANN STDRL F/8 CANN SCR 3MM CANNULATED DRILL BIT W/ QC 3.2MM X 358MM DRILL TIP GUIDE PIN 2.7MM DRILL {} BIT W/QC Spineology Manual Bent Tissue Extractor Brush Catalog# 315-0024 TRAY {} BLADE PLATE INSTS COUNTERSINK {} 1.5/2MM 1.25 WIRE CAP GEN SPECIAL TROCAR PIN 1/8"X3" GNS SAWBLADE- 3M ATTACH 2.7MM PF PIN 40MM LARGE FRAG COUNTERSINK SEMIEXTENDED TAPERED ENTRY TUBE 3.2 DRILL BIT {} 180/165MM NQC 4MM SHORT DRILL CANN DRILL F/HA PINS 3.8MM ROTATOR CUFF REPAIR INSTRUMENTS SUTURE RETREIVER, SMALL, 6 EA Y-Knot RC Disposable Broaching Punch, 2.8mm 4.5 DRILL BIT {} QC 145/120 ACETABULAR PIN PELVIS PIN 2.7MM SHORT DRILL {} BIT W/QC PERI-LOC VLP 2.7MM X 25MM PF PIN SPIR GIGLI SAW BLADE 12 GD RD F/RMR STR 3.2X900MM JET-X TP/ DS FOR 6MM HALF PINS Kyphon Latitude and Express Curettes GNS STRYKER DRILL QUIK CONN 2.7MM DRILL 130MM PERI-LOC CABLE SADDLE TALL 3.2MM TIP THREADED GUIDE WIRE 2MM DRILL 191MM 3.5MM DRILL 191MM GUIDE PIN 3.2MM X 230MM K WIRE TRO PT 1.9X230MM TARGETER 4.5MM DRILL BIT W/QC INT TWIST DRILL - 2.7MM CANN STDRL F/6.4 CANN SCR RT TIB DRILL 4MMX305MM RAD OSTEO BLADE SZ 16 3.2 X 230MM THREADED TIP GUIDE PIN SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, QTY 5 3.2MM X 305MM GUIDE PIN 2 DRILL BIT {} 110MM NQC 4MM CANNULATED TAP W/ QC 3.2 MM GUIDE PIN 3.5MM DRILL {} BIT W/QC HOHMANN RTR B {} 8MM WIDTH 3.5MM NEUTRAL LCK HOLE INSRT REVERSE VERBRUGGE {} 240MM ASIAN IMHS 3.2 GUIDE PIN PERI-LOC 2.7MM DRILL GUIDE PF PIN 25MM 1.8MM CANNULATED DRILL BIT W/QC GUIDE PIN BAY PT 1.3X140 600MM BALL TIP GUIDE ROD GUIDE PIN TIP THRD 1.9 X 300MM Kyphon Osteo Introducer Devices MANOS Carpal Tunnel Release System 3.2 TIP THREADED GUIDE WIRE CODA CTR HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 1.6 X 356MM (62 X 14IN) GEN TROCAR PIN 1/8 GNS AH/STRY RMR/JAC QUIK CONN SCREW DRIVER RELEASE HANDLE DRILL SH 6MM HALF PIN STERILE 2MM PF PIN {} AO CONNECT 18MM GENII SAW BLADE LONGER REFL ACET SCREW DRILL 35MM LENGTH SPECTRUM II SUTURE HOOK, DISPOSABLE, MEDIUM CRESCENT, QTY 5 HYPERFLEX GUIDEWIRE, NITINOL, 18.5 IN, STERILE, 1.6 X 470MM (62 X 18.5IN) EXTENDED LENGTH SPECTRUM MVP SUTURE PASSER, DISPOSABLE, CRESCENT, MEDIUM, QTY 3 HIGH STRENGTH GUIDE PIN, 9 IN, STERILE, 2.4 X 229MM (93 X 9IN) 4MM LONG AO PILOT DRILL 2.5 DRILL BIT {} QC 180/155 GOLD 4.5MM CANN DRILL {} BIT W/QC TARGETER 2.7MM DRILL BIT W/QC 2.7MM TAP W/QC GD RD F/RMR CVD 3.2X900MM PIN DRIVER 4.5 DRILL BIT {} 180/165MM NQC SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE RIGHT, QTY 3 SPECTRUM II SUTURE HOOK, DISPOSABLE, SMALL CRESCENT, QTY 5 SPECTRUM II SUTURE HOOK, DISPOSABLE, STRAIGHT, QTY 5 ToggleLoc System Kyphon V Vertebroplasty Devices GRAFT PASSER 10 EA SPECTRUM II SUTURE HOOK, DISPOSABLE, 60 DEGREE LEFT, QTY 5 3.2MM X 300MM DRILL BIT W/QC REVERSE VERBRUGGE {} 190MM PERI-LOC SM FRAG INST & IMPLANT SET 3.5MM DRILL W QC GD RD F/RMR BL TP 2X700 4.5MM X 90MM CANNULATED DRILL SPIR GIGLI SAW BLADE 20 3.2 X 300 DRILL TIP GUIDE PIN REFL ACET SCREW DRILL 25MM SPECTRUM II, SUTURE HOOK, DISPOSABLE, 60 DEGREE RIGHT, QTY 5 PARASMILLIE BLADE 10MM, QTY 5 SPECTRUM MVP SUTURE PASSER, DISPOSABLE, CRESCENT, MEDIUM, QTY 3 EXTENDED LENGTH SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE LEFT, QTY 3 ROTATOR CUFF REPAIR INSTRUMENTS SUTURE RETRIEVER, LARGE, 6 EA EXTENDED LENGTH SPECTRUM MVP SUTURE PASSER, DISPOSABLE, 45 DEGREE RIGHT, QTY 3 SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5 CONCEPT SUTURE PASSER NEEDLE, QTY 5 PARASMILLIE BLADE 9MM, QTY 5 ROTATOR CUFF REPAIR INSTRUMENTS SUTURE RETRIEVER, MEDIUM, 6 EA BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 1.1 X 356MM (45 X 14IN) DRILL, 2.4MM BIOSCREW GUIDEWIRE, SST, 14 IN, STERILE, 1.1 X 356MM (45 X 14IN) SPECTRUM II SUTURE HOOK, DISPOSABLE, LARGE CRESCENT, QTY 5 Spineology Diverted Fill Tube Catalog# 300-0009 Accessory Portal Kit Spineology Powered Bent Tissue Extractor Brush Catalog# 315-0025 SHUTTLE-RELAY SUTURE PASSING SYSTEM, QTY 10 Spineology Facet Drill Catalog# 315-0015 Spineology Powered Tissue Extractor Brush Catalog# 315-0023 Spineology Manual Tissue Extractor Brush Catalog# 315-0022 ACL Disposable Kit Spineology Straight Fill Tube Catalog# 300-1008 PARASMILLIE BLADE 11MM, QTY 5 BULLSEYE FEMORAL GUIDE END PLUG, QTY 5 DRILL, CANNULATED, 10MM OsteoCool Bone Access Kits Kyphon V Vertebroplasty Kits with CDS Key Surgical® K-Wire and Pin Covers KyphonLatitude and Express Curettes Kyphon Osteo Introducers and OsteoCool Bone Access Devices AMK FIXATION PINS RECLAIM ASSEMBLY TENSILE BAR 2mm AlloMate Instrument System 2.5mm AlloMate Instrument System 0206-711-000;0206-716-000;0206-716-000S2 KYPHON® LATITUDE® II and Express Curettes 3.5mm AlloMate Instrument System 3mm AlloMate Instrument System 4mm AlloMate Instrument System Arthroscopic Disposables Kit Orthoapedic Manual Surgical Instrument Arthroscopic graft delivery kit 4.7mm Knotless anchor drill kit AlloAid® cartilage mixing kit 6198-001-514 Paradigm Relay Labral Suture Passer MISHA™ Knee System Fixation Kit C01 S2268 NeoSpan implant screw kit Access Tool, Fortibrae Access Cannula General Surgical Instrument Concept Suture Passer, needle Super Shuttle Access Tool, Access Cannula Argo Knotless Smooth Punch, 4.75/5.5mm, Disposable Access Tool, Diamond Stylet Graft Guard Bullseye Magic3 GO Pediatric Intermittent Silicone Catheters Magic3 GO Male Intermittent Silicone Catheters ALLEVYN Complete Care 3"x4" Primapad Non-Adherent Dressing 3"x8" Primapad Non-Adherent Dressing Biatain CUD Film Wound Dressing Silflex DUODERM STERILE DRESSING, DUODERM STERILE DRESSING (SIGNAL HYDROACTIVE), BORDER, CG, EXTRA THIN, 2"x3" Reliamed Non-Adherent Dressing Episil Absorbent DUODERM CGF BDR DRS 15X15CM (1X5PK) NAI DUODERM CGF DRS15X20CM (1X5PK) NAI DUODERM SIGNAL 20X20CM (1X5PK) NAI DUODERM SIGNAL 15X18CM (1X5PK) NAI DUODERM XTHIN DRS OVAL (1X20PK) NAI DUODERM CGF BDR DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X20CM (1X5PK) NAI DUODERM SIGNAL 20X22.5CM (1X5PK) NAI DUODERM SIGNAL 14X14CM (1X5PK) NAI DUODERM SIGNAL 20X23CM (1X5PK) NAI DUODERM XTHIN DRS TRG (1X10PK) NAI DUODERM SIGNAL 18.5X19.5CM (1X5PK) NAI Bolin Chest Seal DUODERM XTHIN DRS 10X10CM (1X10PK) NAI DUODERM CGF BDR DRS 6X6CM (1X5PK) NAI DUODERM CGF DRS 15X15CM (1X20PK) NAI DUODERM XTHIN DRS 5X20CM (1X10PK) NAI DUODERM XTHIN DRS OVAL (1X10PK) NAI DUODERM SIGNAL 11X19CM (1X5PK) NAI DUODERM XTHIN DRS 7.5X7.5CM (1X20PK) NAI DUODERM CGF DRS 15X15CM (1X5PK) NAI DUODERM CGF BDR DRS 10X13CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X5PK) NAI DUODERM CGF DRS 20X30CM (1X5PK) NAI DUODERM CGF DRS 10X10CM (1X20PK) NAI DUODERM CGF BDR DRS 15X18CM (1X5PK) NAI DUODERM XTHIN DRS 5X10CM (1X20PK) NAI DUODERM SIGNAL 10X10CM (1X5PK) NAI DUODERM XTHIN DRS 15X15CM (1X10PK) NAI DUODERM DRS 10X10CM (1X20PK) NAI Biatain Silicone ALLEVYN Gentle Stratamed StrataXRT Biatain Silicone Lite Stratacel Allevyn Life H-Vent StrataGRT NelDerm Hydrogel Dressings Derpixa StrataCTX Comfeel Plus Biatain Super Non-Adhesive Band-Aid Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Super Adhesive Adhesive Bandage Coverlet Biatain Silicone Non-border Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Foam Lite ConvaTec Neutrogena Sensitive Skin Blemish Patches Episil Biatain Adhesive CUD+ CTD Dressing wound occlusive Biatain Soft-Hold 2"x3" Primapad Non-Adherent Dressing Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches Hydrocolloid adhesive bandages Compeed Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Biatain Silicone Fit NEXXT MATRIXX Deformity Correxxion Honour Spacer System Grip-Lok Catheter Securement Device Catheter Securement Device Grip-Lok Cath Grip 3300MEPI - Grip Lok 3300MART-KIT-2 - Grip-Lok 3300M - Grip Lok 3309MCS-TA-2 - Grip Lok 3300MW - Grip Lok 3301MCS-BD - Grip Lok 3300MIV - Grip Lok 3300MWA - Grip Lok 3364MCS-BA - Grip Lok 3200S - Grip Lok 2200NUZA - Grip Lok 3460L - Grip Lok 3601CVC - Grip Lok Zpad i.v. Stabilization Device 3600LJCVC - Grip Lok 3306MCS-NA - Grip Lok 2300NUCH - Grip Lok 3500DFN - Grip Lok CathGrip Velano Vascular C/O Cathtek Cathaid CA55 NEXXT MATRIXX PVAC GOLD MASC MAAC PulseSelect™ Pulsed Field Ablation (PFA) Loop Catheter PulseSelect™ Pulsed Field Ablation (PFA) Catheter Interface Cable Freezor MAX Cardiac Cryoablation Catheter NEXXT MATRIXX PFA Therapy Cable PFA Therapy Cable Assy PulseSelect™ Pulsed Field Ablation Loop Catheter PulseSelect™ Pulsed Field Ablation Catheter Interface Cable NEXXT MATRIXX 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 INERTIA CONNEXX Inertia MIS FASTResponder™ Sternal Intraosseous Device Female-to-Female Luer Adapter (FFA-50) Female to Female Adapter Spectris MR Qwik-Fit Syringe Spectris MR Kit with Integral "T" Spectris MR Kit with Integral "T" (SIT 96V) Disposable MRI Kit with Check Valve (SQK 65VS) Disposable MRI Kit with Check Valve (SQK-65VA) Disposable MRI Tubing Set (SIT-96V) MEDRAD® Spectris Disposable MRI Kit with Check Valve (SQK 65VS) MEDRAD® Spectris Disposable MRI Kit with Check Valve (SQK 65VA) MEDRAD® Spectris Solaris 96" (244 cm) MRI Integral “T” with Check Valve for MEDRAD® Spectris MR Injector (SIT 96V) CT TRI-PAK Sterile Disposable Syringe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-07-08
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-09-09
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2024-09-09
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2021-08-13
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2021-08-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-08
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-07-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-08
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2024-09-17
OWV Mesh, Surgical, Collagen, Diaphragmatic Hernia General, Plastic Surgery Class 2 878.3300 2024-09-17
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2024-09-17
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2024-09-17
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2012-10-29
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-09-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-08
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-06-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-06-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-07-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-07-08
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2025-07-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-08
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2024-09-17
OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2024-09-17
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2024-09-17
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2016-06-29
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2016-06-29
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-08
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2020-08-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-11-01
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-09-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-09-09
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2012-12-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-08
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-07-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-07-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-07-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-07-08
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2013-05-07
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-07-08
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2015-10-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-07-08
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2024-02-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-08-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-08-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-08-13
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2012-11-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-07-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-07-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-07-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-07-08
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2021-08-13
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2016-06-29
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-04-19

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
K173198 U&I Corporation Facet Screw Fixation System 2018-01-03
K121850 Choicespine, LP Typhoon(TM) Facet Screw Fixation System 2012-09-20
K033719 C.R. Bard, Inc. BARD TIGERTAIL URETERAL CATHETER 2004-02-04
K820239 American Endoscopy, Inc. RETRIEVAL FORCEPS 1982-03-26
K041243 Tyco Healthcare DOVER RED RUBBER ROBINSON CATHETER 2004-07-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2012 Osteomed, Lp 3885 Arapaho Rd Addison TX 75001 U
OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Z-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0010-2013 C.R. Bard, Inc., Urological Division 2
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0039-2020 AZIYO BIOLOGICS 2
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020 AZIYO BIOLOGICS 2
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009504230. Last updated year: 2026. Please use registration number 3009504230 when referencing this establishment in official correspondence.
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