Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2953359

FEI Number

3000215205

Entity Name

Sterigenics U.S. LLC

City/State/Country

Hayward, CA, US

Establishment Address

2311 Lincoln Ave, Hayward, CA 94545, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CAAP (Calcium Apatite) Bone Wax Bone tamponade CAAP (Calcium Apatite) Bone Wax AeroForm Tissue Expander System Anchor Facet Screw ANCHOR FS Facet Screw Kyphon Anchor Facet Screw System CrossBow Fascial Closure System with Adaptor CrossBow Fascial Closure System Stainless Steel Instruments Xpansion® Forceps DTRAX Spinal System Omiderm Cryosurgical Accessories Visica 2 Probe POGO Automatic Test Cartridges CORUS Spinal System-X CORUS Spinal System-LX Reusable Shielded Cable for concentric + single fiber EMG needle electrode Reusable Shielded Cable Reusable Unshielded Cable for detachable monopolar EMG needle electrode Electrode Cable Thayer Electrode Cable LW Cables and Lead Wires Tech-Attach Connection System CLE Cables and Lead Wires Cabrio Connection System Response EP Cables MYO/Wire® Disposiable Patient Cable 2 Reuasable Unshielded Cable Stimulation Clip MYO/Wire® Disposable Patient Cable 2 Reusable Unshielded Cable Neuroradium Universal Reusable Laryngeal Electrode Cable Reusable Shielded Cable for detachable monopolar EMG needle electrode Disposable Stimulation Clip Shirmer Tear Test Strips Levita Magnetic Surgical System SYNEVAC VACUUM SYSTEM CORUS Navigation Access-GLX Cem-Ostetic Putty AXERA Access System XSTAT-30 XSTAT Chalgren Enterprises Monopolar Electrode for EMG (115-XXX-XX) Chalgren Enterprises Monopolar Electrode for EMG (126-XXX-XX) Natus Monopolar Electrode for EMG (019-40XXXX ) Chalgren Enterprises Monopolar Electrode for EMG (121-XXX-XX) Chalgren Enterprises Monopolar Electrode for EMG (125-XXX-XX) Chalgren Enterprises Monopolar Electrode for EMG (111-XXX-XX) UL400-4; UroLift System X-Stop Interspinous Process Vitreous Cutter Callos ProModel Bone Void Filler Trinica Parallax T-Grip Access Needle KP-TGN-1101-02 DRILL BITS Accesory Porta Kit Access Tool, Cannulated Drill NanoTack Drill Bit CinchLock Drill Bit NanoTack Flex Drill Bit OVERDRILL FOR 2MM SCREWS W/AO QC 2MM DRILL LONG W/AO QC 1.8MM DRILL SHORT W/AO QC 2MM DRILL SHORT W/AO QC 1.5MM DRILL LONG WITH AO QC OVERDRILL FOR 2.4MM SCREWS W/ AO QC ToggleLoc System VLP MINI-MOD 1.5MM OVERDRILL MINI QC MEDTRONIC Facet Screw Instruments JETX 4.8 SHT GRAD STEP DRILL 1.8MM DRILL LONG W/AO QC SpineDriver 2mm bits OVERDRILL FOR 2.7MM SCREWS W/AO QC 14" Guidewire Accessory Portal Kit Quattro Drills ACL Disposable Kit Quattro Bolt Accessory Drill Kits BioWick Drill Kits SureLock Drills Facet Screw Insruments SIGMA HP TROCHLEA CUTTING BIT 3910-075-502;3910-075-652;3910-075-802;3910-090-502;3910-090-652;3910-090-802;0234-020-175 Comprehensive Mini Baseplate Flow-Drill Comprehensive Standard Baseplate Comprehensive Augmented Glenoid Components TOGGLELOC PUSHER CAT02974 CAT02644 VertecoR Bone Drill 3 Kypho Pak Tray DISPOSABLE DRILL TIP Enclose II PMT Posterior Fixation System enCise FlexLite Bone Cutter enVue FlexLite Cannula, Standard Jaw FlexLite Sheath enVue FlexLite Cannula, Long Jaw SutureEase SecurusDL Port Site Closure Device Securus System EzStitich Port Site Closure System 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 11 guage Bone Access Needles Homer Breast Localization Needles OnPharma OnSet Cartridge Connector MiniStop Plus BackStop Plus Monoject Bone Marrow Biopsy Tray with Safety Components PERCUCUT NEEDLES, N105, N110, N115, N710, N715, N810, N815 Turkel Safety Fluid Drainage System Curity Amniocentesis Tray Disposable Needles BONE BIOPSY NEEDLE Curity Thoracentesis Trays with Safety Components Facet Screw Instruments FNA - Fine Needle Aspiration CHIBA NEEDLE MEDTRONIC Facet Screw Instruments Turkel Thoracentesis System: 566059 Turkel Thoracentesis System: 566034 Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed Anesthesia Peribulbar; Retrobulbar Needles Turkel Thoracentesis System: 566075 Monoject Sternal-lliac Aspiration Needle Turkel Safety Thoracentesis Procedural Tray Monoject Basic Bone Marrow Biopsy and Aspiration Tray with Safety Components Monoject Bone Marrow Biopsy and Aspiration Tray with Safety Components Monoject Basic Bone Marrow Biopsy Tray with Safety Components Monoject Bone Marrow Biopsy Prepping Tray with Safety Components Monoject Bone Marrow Biopsy / Aspiration Needle Cardinal blunt fill needle with filter Temporary Sharps Holder "ShortStopGrandstand Cardinal blunt fill needle wwithout filter Word Bartholin Gland Catheter Ocutek Clearance Assistant Plus ALLY Bone Screw ALLY Bone Screw-LX Vitreous Cutter 989603203484 MRI Needle Block 18G 989603203464 MRI Needle Block 12G 989603203494MRI Needle Sleeve 12G 989603214204 Biopsy Grid, Sterilized [Box] 989603209104 Pillar Immobilization Plate Guide, Needle, Surgical, Cassi 2 Needle PP206 PP1715 PP196 PP2015 PP2010 PP1515A Tiger Needle Express with Broach Tiger Needle Express PP13510 PP1510A PP176 PP1710 PP1356 PP156 PP1915 Tiger Needle PP1910 Tiger Cub Argon Arterial Needle 989603203534 Pillar Immobilization Plate 989603209134 Grid Plate- Enhanced Access Lateral 989603204304 MRI Needle Block 16G 989603209094 Pillar Immobilization Plate LBS M-L 989603203564 Fiducial Holder 989603203604 Needle Hub Assembly 989603209084 Grid Immobilization Plate LBS M-L 989603203544Needle Block Holder 989603216902 Sentinelle Biopy Grid, BOX 459801507722 Biopsy Grid, Sterilized [Pouch] 459801813442 Sentinelle, Biopsy Grid [Pouch] 989603209064 Grid Immobilization Plate LBS 989603210893 Lateral Grid, Upper dS Breast 16CH I/T 989603209154 Medial Grid dS Breast 16CH 1/T 989603203454 MRI Needle Block 8G 989603203504 MRI Needle Sleeve 14G 989603209144 Lateral Grid dS Breast 16CH 1/T 989603204314 MRI Needle Sleeve 16G 989603209074 Pillar Immobilization Plate LBS C-C 989603203524 Grid Immobilization Plate 989603210903 Lateral Grid, Lower dS Breast 16CH I/T 989603209124 Grid Plate- Enhanced Access Medial 989603203584 Mammotome Immobilization Plate 989603214224 Breast Grid (User-sterilized) [Box] 989603203474 MRI Needle Block 14G 989603203514 MRI Needle Sleeve 18G 989603203594 OBC Grid Immobilization Plate Microcutter 30 White Reload Microcutter 30 Curved Tip White Reload Microcutter 5/80 Stapler Microcutter 30 Curved Tip Blue Reload Microcutter 30 Blue Reload Enluxtra Eeva Petri Dish Callos Bone Void Filler (CMC) Vitreous Cutter Guide Pin 2.4 x 508 R/R Package ASM, No. 300-1011 DS Portal Tube Package ASM, No. 550-0013 Guide Pin 2.4 x 508 T/R Package ASM, No. 300-1010 Guide Pin 1.1 x 635 Package ASM, No. 430-0041 Portal Tube Package ASM, No. 315-0016 StabiliT Introducer 3.6-11.5-EB 42-3100 FlexDex Needle Driver StabiliT Delivery Instruments, Short StabiliT Introducer 3.6-11.5-ED INSTRUMENT, MANUAL, SURGICAL, GENERAL USE DermaBlade® 2.4MM ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, 4 EA StabiliT Introducer 3.6-D StabiliT Delivery Instruments, Long HIGH STRENGTH BREAKAWAY GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN) StabiliT Introducer 3.6-B Locking Delivery Cannula 3-11.5-ED HIGH STRENGTH BREAKAWAY GUIDE PIN, 9 IN, STERILE, 2.4 X 229MM (93 X 9IN) 45 DEGREE BLITZ SUTURE RETRIEVER, LEFT, 6 EA Spineology Guide Pin Catalog# 300-1011 Locking Delivery Cannula 3 Spineology Guide Pin Catalog# 530-0089 Spineology Guide Pin Catalog# 530-0088 Spineology Guide Pin Catalog# 430-0041 Spineology Guide Pin Catalog# 530-0087 2.4MM ARTHROSCOPY KNIFE, SMILLIE, SMALL JOINT, QTY 4 BIOSCREW HYPERFLEX GUIDEWIRE, NITINOL, 14 IN, STERILE, 0.8 X 356MM (32 X 14IN) SE GRAFT TENSIONER BREAKAWAY PINS WITH GRAFT TENSION CALCULATOR, QTY 5 ARTHROSCOPY KNIFE, RETROGADE, SMALL JOINT, 2.4mm, QTY 4 45 DEGREE BLITZ SUTURE RETRIEVER, RIGHT, 6 EA Spineology Diverted Fill Tube Catalog# 300-0009 SUTURE SAVER KIT, QTY 5 Spineology Guide Pin Catalog# 300-1010 MedOne Guide Pin 2.4 x 508 T/R Package ASM, #300-1010 Guide Pin 1.1 x 635 Package ASM, #430-0041 Yankauer Suction Device DS Portal Tube Package ASM, # 550-0013 Portal Tube Package ASM, # 315-0016 NM Dilator One, #315-0012 DermaBlade Guide Pin 2.4 x 508 R/R Package ASM, #300-1011 Trocar Cleaner - XL 12 mm Crosstrees Pod, 18 X 20 mm Crosstrees Pod, 18 X 15 mm TrabTM360 Surgical Instrument IVX Station Transfer Set Sterile Surgical Needles MENISCAL REPAIR NEEDLE 10 EA Quattro Suture Needle Double Foam Strips 60-120 Count ½ Magnet ½ Foam Strips 80 Count with Blade Remover Double 30 Count Magnet/Single Foam Block 40 Count w/ Blade Remover 1/2 Foam Strips 1/2 15 Count Magnet Clear Top 10 Count Magnet Magnet/Foam Block 20-40 Count Magnet/Foam Strips 30-60 Count Double Magnet 60-120 Count 1/2 Foam Strips 1/2 Black Magnet 30-60 Count w/ Blade Remover Double Foam Block 40-80 Count Double Magnet w/o Numbers Double Foam Block 80-160 Count Blank Double Magnet 60 Count Yellow Needle Counter Magnet/Foam Block 20-40 Count w/ Blade Remover Double Magnet White Blade Remover Double 60 Count Magnet Foam Strip/Magnet 40 Count Blade Remover 1/2 Mag 1/2 Adhesive 10 Count 1/2 Magnet 1/2 Foam Block 20-40 Count w/ Blade Remover Clear Top 30 Count Magnet Syringe Cup Clear Suture Bag w/ adhesive - Large Clear Suture Bag w/ adhesive Single Magnet 30 Count Safety Stop w/Plastic Box Temp. Sharps Holder Foam Strip/Adhesive Needle Counter Large 10 Count 1/2 Magnet 1/2 Foam Block Double Magnet 20-40 Count Suture Bag 8x10 Double Magnet 60 Count (Deep Box) Magnet/Foam Block 20-40 Count. Private Labeled ROI(ROI# 236172) Needle Counter ½ Magnet ½ Foam Block 40-80 Count with Blade Remover Foam Block/Magnet 40 Count Single Magnet 10-20 Count Needle Counter 1/2 Magnet/ 1/2 Foam Block 40-80 Ct. Private Labeled for ROI(ROI# 236173) Magnet/Foam Strips 30-60 Count. Private Labeled for ROI(ROI# 236170) Adhesive/Foam Block 20-40 Count Needle Counter 1/2 Magnet 1/2 Foam Block 40-80 Count Needle Counter Foam Block/ Magnet 10 Count Needle Counter 1/2 Adhesive 1/2 Foam Strips w/ Slits ½ Foam Block ½ Adhesive 40-80 Count with Blade Remover Double Magnetic Strips 60 Count Needle Counter w/ Blade Remover, Yellow Magnet/Foam Block 40-80 Count Adhesive/Foam Block 10 Count Magnet/Foam Strips 60-120 Count Blank Double Magnet Small 10 Count Foam Block Double Magnet w/Blade Remover 30 Count 1/2 Foam Block 20 Count Private Labeled 70931 Needle Counter- Double Blank Magnets w/ Blade Remover - Lifecell Double Magnet 30-60 Count Adhesive/Foam 20-40 Count Needle Counter Large 10 Count 1/2 Adhesive 1/2 Foam Block Introducer Needle NDL16-6, 16g needle 6" long Introducer Needle NDL16-8, 16g needle 8" long Introducer Needle TUN13-10, 13g tunneler 10" long Introducer Needle NDL16-10, 16g needle 10" long Introducer Needle NDL16-4, 16g needle 4" long Natus Low Profile Electrode for EEG (019-77XXXX ) Chalgren Enterprises Injectable Monopolar Electrode for EMG (242-XXX-XX) Chalgren Enterprises Low Profile Electrode for EEG (221-XXX-XX) ViscoInjector System Visica ICE Probe Unit, Cryosurgical Accessories Visica 2 Probe Magellan Robotic Catheter 9Fr Caddy Magellan Robotic Catheter 9Fr (50cm, 65cm, 80cm) Magellan Robotic Catheter 9Fr Accessory Kit (50cm, 65cm, 80cm) VASCADETM 6/7F Vascular Closure System VASCADETM 5F Vascular Closure System VASCADE MVP VASCADE 6/7F VASCADETM MVP Venous Vascular Closure System VASCADE 5F VASCADE MVPTM 6-12F Venous Vascular Closure System VASCADETM MVP XL Venous Vascular Closure System Ophthalmic catheter kit Canaloplasty microcatheter iTrack 250A AXERA 2 Access System CAVUX Facet Fixation System, 4mm VISCO360 Viscoelastic Injector Propel Device, RT open / Closed Propel Device, XL DTRAX Spinal System UL2-C; UroLift 2.2 Implant Cartridge UL2-CHK; UroLift 2.2 Implant Cartridge and Delivery Handle Kit All Galaxy II codes Galaxy II Reddick Saye Screw Retractor Kit DTRAX Spinal System Cardica PAS-Port Cardica Pas-Port Guide Wire Insertion Device BowTie GABBAY-FRATER 1.3MM X 2.7MM DRILL GUIDE DTRAX Spinal System P-L VLP UNIV DRILL GDE HANDLE W PVT HD MEDTRONIC Facet Screw Instruments TRIPLE DRILL GUIDE Prostate Needle Guide KYPHON® Introducer Tool Kit THE SNAKE Zimmer Guide Pin Facet Screw Insruments Ad-Tech Sleeve Guides Wire Caddy Needle Guide Guide, surgical, instrument LAA Selection Guide CORUS Navigation Access System Visica ICE Probe SL Aveta Disposable Resecting Device Aveta Disposable Resecting Handset Amcon Laboratories Tear Flow Test Strips Parallax T-Grip Access Needle Autologous Platelet Concentrator Fluid Transfer Device (FTD) Access Tool, Filler Placement Stylet nContact Cannula Caps-Lock Ultra Access Tool, Filler Placement Set VertecoR MidLine Osteotome 3 Ad-Tech Cannulas Cannula Surgical General and Plastic Surgery Cassi 2 Needle MEDTRONIC Facet Screw Instruments Bone Plug And Obturator ACL Disposable Kit Facet Screw Insruments 2-CAN Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed Topaz EPF Cannula System Repris Bladder Injector (1017) Vitreous Cutter CAVUX Cervical Cage-B CAVUX Cervical Cage-SE CAVUX Cervical Cage-X CAVUX Cage-LX, 4mm CAVUX Cage-LX, 5mm Vitreous Cutter AXERA Access System wound care dressing Bridge Dressing Kit (BKTF14X11 & BKTF14x1110) wound care accessory Blue Foam (18x18, 13x13, 8x8) wound care dressing SNaP Hydrocolloid Dressing (SLTA10X10, SLTA15X15, SLTA20X20, SLTB14X11) Locking Syringe RegenMed Marrowminer C-Port xA Cardica C-Port xA OMNI Edge Surgical System mild Device Kit Y-Type TUR Irrigation Set Crosstrees Pod, 18 X 20 mm T.U.R. Irrigation Set APEX Ceruleau 24 K Specail Decanting Set 10 K Crosstrees Pod, 18 X 15 mm Arthroscopic Irrigation Set Cystoscopy Irrigation Set SYNEVAC CUETTAGE SYSTEM AeroForm ClariFix Transfer Bag 600ML - 732-33M Transfer Bag, CLX 1000ML - 732-37M Transfer Bag, 600ML, Multi-Lead Set - 732-40M Transfer Bag 1000 ML (MEDTRONIC) - ATBAG1000 Transfer Bag 300 ML (MEDTRONIC) - ATBAG300 Transfer Bag, 400ML, Barrel Leads - 732-42M Transfer Bag 300 ML - 732-32M Transfer Bag 600 ML (MEDTRONIC) - ATBAG600 Transfer Pack - NFP450 TRANSFER PACK NFP450E TRANSFER PACK NFP450B Vessel Dialators Dialator AXERA 2 Access System StabiliT MX Fracture Kit with PowerCURVE, Base, Long StabiliT Second Fracture Kit with PowerCURVE, Short StabiliT First Fracture Kit with PowerCURVE, Long StabiliT First Fracture Kit (Blister Pack), Short StabiliT Complete Fracture Kit with PowerCURVE, Long StabiliT MX Fracture Kit with PowerCURVE, Full, Long StabiliT First Fracture Kit (Blister Pack), Long StabiliT Complete Fracture Kit with PowerCURVE, Short StabiliT First Fracture Kit with PowerCURVE (Blister Pack), Short StabiliT Mx Fracture Kit with PowerCURVE, Base, Short StabiliT MX Fracture Kit with PowerCURVE, Full, Short StabiliT Second Fracture Kit with PowerCURVE, Long StabiliT MX Fracture Kit with PowerCURVE, Full, Short StabiliT Second Fracture Kit with PowerCURVE, Short StabiliT Second Fracture Kit with PowerCURVE, Long StabiliT First Fracture Kit with PowerCURVE (Blister Pack), Short StabiliT First Fracture Kit (Blister Pack), Short StabiliT MX Fracture Kit with PowerCURVE, Full, Long StabiliT Mx Fracture Kit with PowerCURVE, Base, Short StabiliT MX Fracture Kit with PowerCURVE, Base, Long StabiliT First Fracture Kit with PowerCURVE, Long StabiliT First Fracture Kit (Blister Pack), Long StabiliT Complete Fracture Kit with PowerCURVE, Long StabiliT Complete Fracture Kit with PowerCURVE, Short Smart External Drain (SED) System 329.634S 329.632S 3601S 351.27S 329.633S 35986S 35113S PLASTIC TEMPLATE FOR CATHETER PLACEMENT GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (93 X 17IN) HIGH STRENGTH GUIDE PIN, 14 IN, STERILE, 2.4 X 356MM (93 X 14IN) HIGH STRENGTH GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN) LCS PAT PLAN REP BASK STD/STD+ GLOBAL AP BALL CYLIN TRL ASSEM GLOBAL AP REVISION TRL INSERT MISHA Knee System Targeting Kit MISHA Knee System Trial Access Tool, Strike Plate Extension Access Tool, Strike Plate Humeral Guide Wire enVue Cannula, Long Jaw MIS Decompression System Accessories, Short MIS Decompression System Accessories, Long enVue Cannula, Standard Jaw enCise Bone Cutter CoSeal Surgical Sealant, 4 mL, US (premix) Replacement Applicator, CoSeal Surgical Sealant, US and International (5 per box) CoSeal Surgical Sealant, 2 mL, US (premix) Extended Applicator, CoSeal Surgical Sealant, US and International (10 per box) CoSeal surgical Sealant, 8 mL, US (premix) Coseal Coseal Surgical Sealant Vitreous Cutter Clearance Assistant Plus Clearance Assistant 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 VBS X-Change Cement Dispensing Syringe Delivery Syringe & Stopcock Master Syringe Assembly Hydraulic-Master Syringe Assembly Hydraulic Assembly Injector, Vertebroplasty (does not contain cement) 0306-140-000 0306-080-000 0306-150-000 0306-310-000 0306-081-000 0306-114-000 0306-530-000 0306-160-000 0306-134-000 0306-330-000 0306-531-000 0306-511-000 0306-331-000 CDAK008 Single use, sterile procedural tray/kit AVAtex Cement Delivery Accessory Kit 8G CDAK011 Single use, sterile procedural tray/kit AVAtex Cement Delivery Accessory Kit 11G CDAK010 Single use, sterile procedural tray/kit AVAtex Cement Delivery Accessory Kit 10G Microcutter Xchange enSpire Microdiscectomy System enSpire Cervical Discectomy System Catalyst II VCS Access Tool, Biopsy Set EXICLIP EXCS-M Kyphon Bone Biopsy Devices MISHA Knee System Ad-Tech Passing Needles CrossFix II Disposable Kit CORUS Guide Tube Adapter CORUS Spinal System wound care accessory Blue Foam (18x18, 13x13, 8x8) Callos CMF Bone Void Filler Bone void filler Callos CMF Bone Void Filler Smart External Drain (SED) System Instrument, Biopsy Cassi 2 Needle Chalgren Enterprises Monopolar Electrode for EMG (110-XXX-XX) XSTAT 12 Axxent Balloon Applicator InterSep Calcium Sulfate Kit Assembly InterSep Ceruleau Catalyst III VCS SpineSTAR Ablation Instrument 5 10, Short, Gen 2 SpineSTAR Ablation Instrument (10 15) SpineSTAR Ablation Instrument (10 15), Short, Gen 2 STAR Tumor Ablation Kit with PowerCURVE STAR Tumor Ablation Kit with PowerCURVE,(1015, Long) AE Cable Hand Switch Cable STAR Tumor Ablation Kit Veloxion Resectoscope BANDAGE ELASTIC COTON BULK NON STERILE 2 inch 3 inch 4 inch 6 inch SPONGES GAUZE NON STERILE BULK 4X4 16PLY SPONGES GAUZE NON STERILE BULK 3X3 12 PLY SPONGES GAUZE NON STERILE BULK 4X4 16PLY GAUZE WASHED BOLT NON STERILE BULK TOWELS COTTON NON STERILE BULK SPONGES GAUZE NON STERILE BULK 2X2 8 PLY COTTON BALLS MEDIUM AND LARGE NON STERILE BULK STOCKINETTE COTTON APPLICATOR ABSORBENT TIPPED NON STERILE BULK SPONGES GAUZE NON STERILE BULK 4X4 8 PLY SPONGES GAUZE NON STERILE BULK 4X4 12 PLY Surgical Instrument Kit Disposable Sterilized Convenience Kit ACL DISPOSABLE KIT PDP101/20 CIR011/20 BBF005/10 TRT120/10 CHT007/20 CHT009/20 9204/20 UCPT01/10 SUTGEN001/100 VST405/20 LAC137/20 DISPOSABLE PERCUTANEOUS PACK FOR C617X REUSABLE GUIDES BBF001/10 CHT013/20 DBFK01/10 LAC141/20 BBF007/10 BBF002/10 HDT300/20 SMR001/20 LAC147/20 LAC134/20 THT706/20 HDT010/10 DCNS01/20 ENDO01/20 LAC107/20 CHT032/20 VST406/20 PBT001/20 EMR009/20 ENT003/20 NSL008/20 LAC109/20 LAC701/20 LAC122/20 SJT001/10 SNBS01/05 CDT703/05 CIR-1937 DBR001/20 CHT010/10 CIR001/20 ENT002/10 CHT005/20 CHT007/10 PWL001/20 TBT100/10 SMH001/05 24-685/20 SUT112/50 OKD001/10 EMR707/10 CHT004/10 LAC133/20 UBT001/20 BBF012/05 CJD006/01 PLT001/20 DERM01/20 NSL001/20 BMB001/20 TRT125/10 LAC146/20 BBF009/10 NHH001 PART 1 17472/20 SUT036/20 SSK119R/06 BBF015/05 ToggleLoc 2.9 0TOQ234 SUT009/20 PRP101/25 EMR007/20 SUT120/20 SSK124/06 TRT110/20 EPI002/20 SUT113/50 LAC103/20 DRS001/50 CIR220A/20 EMR013/20 INC03/20 SUT125/50 ASB001/10 PCRS01/10 Y-KNOT FLEX DISPOSABLE PERCUTANEOUS PACK FOR Y-G00X REUSABLE GUIDES HIP ARTHROSCOPY DISPOSABLE KIT ANATOMIC ACL DISPOSABLE KIT CPCT01/20 BBF008/10 SSK120/06 CHT012/20 SPIP01/20 BPT408/20 SUT106/50 JuggerLoc Y-KNOT FLEX 1.3MM DISPOSABLE PERCUTANEOUS PACK WITH T-GUIDE MOK001/50 SUT292/50 INST10/50 IUDKS1/20 LAC131/20 SUT130/50 HPK002/20 DCPD01/20 STARNT/20 CBK018/20 SUT035/20 DBR006/50 CJD001/01 19082/20 PLV014/20 NCK400/10 SUT866/50 HDT200/20 CJD003/01 PRK001/20 ENT003/10 TRT710/05 OBG001/20 PRP009/20 MPP001/20 SSK125/06 TRT122/10 NSL003/20 LAC117/20 ASB002/10 TRT121/10 UNIVERSAL ACL DISPOSABLE KIT CIR100/20 MHH001/10 CJD002/01 DCK001/10 CHT010/20 BBF006/10 INST11/20 EMR710/10 CGCM01/10 BBT003/20 INC15/20 TOQ232 DPHP01/20 CHT019/20 LAC139/20 LAC138/20 CDT701/05 CIR601/20 NBT001/5 CIR039/20 BBF011/10 NAZB01/10 SUT123/20 CJD005/01 TRT126/10 SSK119/06 DRS006/20 SBT210/20 LAC132/20 LAC290/20 CHT002/20 EMR002/20 BBF013/10 OEPT01/20 DERM02/20 PRP008/20 SUT401/50 LAC333/20 LAC126/20 LAC866/20 MST202/20 SSK149/06 DCH002/20 WHK002/50 LAC142/10 MOK001/25 LAC121/20 SSK121/06 NPT002/20 QMC001/10 EMR008B/20 BPT406/20 NCK310/10 TOQ233 VAT706/20 PBF001/10 DBR009/20 PCT001/20 CDT202/20 VT 100 Y - Connector THT001/10 MOHS02/20 PCK001/20 BFK001/10 LAC501A/50 MGH001/10 CHT015/10 SPA001/20 THT201/20 CHT021/10 SSK100/06 TRT019/10 NHH001/05 OBG004/20 BBF018/10 TOQ234 VT Drape and Port Set Kit S Lock CHT006/10 PLV013/20 SUT110/20 PLT002/10 KHBF01/10 LAC124/20 DAT001/10 Carilex VT Extension Tube CIR010/20 FPK013/20 INC40/20 SUT121/20 LAC120/20 CPDK01/100 BBF014/10 CHT030/10 LAH001/10 SUT124/50 ADK001/05 CIR301/20 VT Port Set Kit VT Drape 5pcs pack VT Circle Drape 5pcs pack VT Drape and Port Set Kit L Lock VT Drape and Port Set Kit M Lock Surgical Instrument Tray (SIT) Kit GENERAL PURPOSE KIT, INCISION AND DRAINAGE KIT VT. 100 Y - Connector JuggerLoc and ToggleLoc 2.9 MedOne WishBone Convenience Kit Heating Tip Accutip OSI200 Implant Template Propel Device PT contra angle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2018-03-22
MTJ	Wax, Bone	Unknown	Class U	N/A	2012-11-08
PQN	Carbon Dioxide Gas Controlled Tissue Expander	General, Plastic Surgery	Class 2	878.3510	2018-03-22
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2012-11-01
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2018-07-27
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2018-07-27
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-11-01
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-09-11
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2018-07-16
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2013-03-20
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2019-12-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-07-31
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2012-11-12
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2012-11-12
PNL	Magnetic Surgical System	General, Plastic Surgery	Class 2	878.4815	2017-07-05
HHI	System, Abortion, Vacuum	Obstetrics/Gynecology	Class 2	884.5070	2012-11-12
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2025-08-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-05-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-10-30
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2018-03-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-10-24
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	General, Plastic Surgery	Class 2	878.4452	2016-02-02
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2012-11-12
PEW	Implantable Transprostatic Tissue Retractor System	Gastroenterology, Urology	Class 2	876.5530	2021-02-09
NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown	Class 3	N/A	2012-11-01
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2017-07-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-11-12
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-11-01
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-11-12
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2019-12-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-11-12
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2014-02-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-11-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-11-01
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-11-01
PNL	Magnetic Surgical System	General, Plastic Surgery	Class 2	878.4815	2021-02-09
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2012-11-07
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-05-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-07-31
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2013-03-20
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-20
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-10-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-03-20
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2012-11-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2012-11-08
HKP	Instrument, Vitreous Aspiration And Cutting, Battery-Powered	Ophthalmic	Class 2	886.4150	2013-03-20
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2016-08-31
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-11-01
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2012-11-12
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2014-01-30
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2014-01-30
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2025-08-08
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2014-02-06
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2023-06-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-06-13
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-10-30
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2012-11-12
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2014-02-06
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2013-03-20
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-03-20
DXX	System, Catheter Control, Steerable	Cardiovascular	Class 2	870.1290	2014-08-12
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2014-08-12
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2014-01-30
PEW	Implantable Transprostatic Tissue Retractor System	Gastroenterology, Urology	Class 2	876.5530	2024-09-09
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2013-03-20
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-01-23
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2026-05-07
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2018-07-27
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2017-07-05
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2021-02-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-07-31
PEW	Implantable Transprostatic Tissue Retractor System	Gastroenterology, Urology	Class 2	876.5530	2021-02-09
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-11-16
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2012-11-12
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-11-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-08-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-11-12
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2024-09-09
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-07-05
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2023-04-25
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2023-04-25
KYD	Strip, Schirmer	Ophthalmic	Class 1	886.1800	2018-03-09
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-01
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2012-11-12
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-02-09
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2013-03-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2025-08-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2017-07-05
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2013-03-20
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2023-06-13
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2023-06-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-10-24
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	General, Plastic Surgery	Class 2	878.4683	2013-03-19
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2014-03-30
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2012-11-12
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2023-07-31
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2026-05-07
MRH	Pump, Infusion, Ophthalmic	General Hospital	Class 2	880.5725	2026-05-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-11-07
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-10-30
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2012-10-30
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2012-11-12
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2012-11-07
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2017-07-05
PQN	Carbon Dioxide Gas Controlled Tissue Expander	General, Plastic Surgery	Class 2	878.3510	2017-06-26
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2018-03-22
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2013-01-26
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2012-11-12
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2017-07-05
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-05
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-07-05
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2019-12-02
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2019-12-02
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2015-01-02
HWT	Template	Orthopedic	Class 1	888.4800	2013-07-17
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-11-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-11-12
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2012-11-12
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2013-03-20
HNS	Expressor	Ophthalmic	Class 1	886.4350	2023-07-31
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2012-11-12
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2012-12-17
PEW	Implantable Transprostatic Tissue Retractor System	Gastroenterology, Urology	Class 2	876.5530	2021-02-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-01-23
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-09-09
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-11-12
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-11-12
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2012-11-01
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-02-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-08-08
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2025-08-08
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2025-08-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-11-12
QVV	Medial Knee Implanted Shock Absorber	Orthopedic	Class 2	888.3610	2024-09-09
HWQ	Passer	Orthopedic	Class 1	888.4540	2012-12-04
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2012-11-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-07-31
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	General, Plastic Surgery	Class 2	878.4683	2013-03-19
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2012-11-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-11-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-12
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2018-03-22
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-03-22
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2012-11-12
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2012-11-12
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use	General, Plastic Surgery	Class 2	878.4452	2017-02-16
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2012-11-12
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2021-02-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-11-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-12
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2014-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-12
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2023-07-31
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2023-07-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-31
HWJ	Awl	Orthopedic	Class 1	888.4540	2023-06-13
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-05-13
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-11-14
PNL	Magnetic Surgical System	General, Plastic Surgery	Class 2	878.4815	2026-05-07
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2012-11-12

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.

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Other Registrations for Same Entity

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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
K082659	Covidien Lp, Formerly Registered AS United States	MODIFIED ENDO STICH	2008-09-19
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2953359. Last updated year: 2026. Please use registration number 2953359 when referencing this establishment in official correspondence.