FDA Registration Active 🇺🇸 United States

Sterigenics Radiation Technologies, LLC

Reg #: 2024024 · FEI: 2024024 · Expires 2026
Products
91
Proprietary Names
683
Establishment Types
3
Classifications
91

Registration Details

Registration Name
Sterigenics Radiation Technologies, LLC
Registration Number
2024024
FEI Number
2024024
Status
Active
Expiry Year
2026
Initial Importer
No
Address
7695 Formula Pl
City
San Diego
State
CA
ZIP
92121
Country
US

Owner / Operator

Firm Name
Sotera Health LLC
Operator Number
10029425
Address
2015 Spring Road, Suite 650
City
Oak Brook
State
IL
Postal Code
60523
Country
US
Correspondent
Karen Whaley-Krumins

Products

Device Name Product Code
Bone Grafting Material, Human Source NUN
Temporary Carotid Catheter For Embolic Capture NTE
Filler, Bone Void, Calcium Compound MQV
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
Set, Administration, Intravascular FPA
Plate, Fixation, Bone HRS
Screw, Fixation, Bone HWC
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY
Biologic Material, Dental NQA
Tubing, Fluid Delivery FPK
Electrode, Cutaneous GXY
Appliance, Fixation, Spinal Intervertebral Body KWQ
Set, I.V. Fluid Transfer LHI
Abutment, Implant, Dental, Endosseous NHA
Stopcock, I.V. Set FMG
Cleanser, Root Canal KJJ
Wire, Guide, Catheter DQX
Cover, Burr Hole GXR
Fastener, Plate, Cranioplasty HBW
Folders And Injectors, Intraocular Lens (Iol) MSS
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
Mesh, Surgical, Polymeric FTL
System, Skin Closure MKY
Sensor, Glucose, Invasive MDS
Catheter, Percutaneous DQY
Electrode, Needle GXZ
Plate, Bone JEY
Integrated Continuous Glucose Monitoring System For Professional Retrospective Use QDL
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management QDK
Electrosurgical, Cutting & Coagulation & Accessories GEI
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
Stents, Drains And Dilators For The Biliary Ducts FGE
Syringe, Piston FMF
Micro Pipette JRC
Prosthesis, Tracheal, Expandable, Polymeric NYT
Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use PYO
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use QII
Bone Grafting Material, Synthetic LYC
Wound Dressing With Animal-Derived Material(S) KGN
System, Suction, Lipoplasty MUU
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Stent, Iliac NIO
Dressing, Wound, Drug FRO
Stent, Coronary MAF
Mesh, Surgical FTM
Agent, Absorbable Hemostatic, Collagen Based LMF
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
Mesh, Surgical, Collagen, Diaphragmatic Hernia OWV
Stent, Carotid NIM
Needle, Hypodermic, Single Lumen FMI
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX
Collagen Corneal Shield MOE
Set, Tubing And Support, Ventilator (W Harness) BZO
Pericardial Patch To Facilitate Revision Surgeries OMH
Fiber, Medical, Absorbent FRL
Implant, Endosseous, Root-Form DZE
Coronary Drug-Eluting Stent NIQ
Tubes, Gastrointestinal (And Accessories) KNT
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Catheter, Straight EZD
Mesh, Surgical, Metal EZX
Catheter, Intravascular, Diagnostic DQO
Knife, Ophthalmic HNN
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant PNW
Dispenser, Cement KIH
Implantable Pacemaker Pulse-Generator DXY
Pulse Generator, Permanent, Implantable NVZ
Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
Dressing, Wound, Hydrophilic NAC
Absorbable Coronary Drug-Eluting Stent PNY
Pulmonary Valve Prosthesis Percutaneously Delivered NPV
Accessories, Implant, Dental, Endosseous NDP
Wax, Bone MTJ
Clip, Implantable FZP
Stent, Renal NIN
Catheter, Angioplasty, Peripheral, Transluminal LIT
Barrier, Synthetic, Intraoral NPK
External Mandibular Fixator And/Or Distractor MQN
Shunt, Central Nervous System And Components JXG
Device, Monitoring, Intracranial Pressure GWM
Scaffold, Infrapopliteal, Absorbable NXW
Tape And Bandage, Adhesive KGX
Clamp, Vascular DXC
Device, Vascular, For Promoting Embolization KRD
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK

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 Electrode, Cutaneous EMG Leads and Extensions EMG Leads and Extensions, (Model No. RS-ETL) Screws and plates Mystique Provide® Protection Cap 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 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 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 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¿) 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 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 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) 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 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) 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 Vasculon Plus Catheter, intravascular, therapeutic, short-term less than 30 days NovaBone MacroFORM mesh, surgical XenMatrix, DermMatrix Porcine surgical mesh; dermal matrix Xen Matrix Surgical Graft Bioresorbable bone fixation device Telamon, Cornerstone, Mesh SurgiWrap FROST 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 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 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 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 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 PROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 4MM POST PROVIDE® IMPRESSION COPING 4.8MM(P) - 5.5MM POST DRILL STOP, 2.3MM-3.25MM X 15MM PROVIDE® IMPRESSION COPING 6.5MM(P) - 5.5MM POST DRILL STOP, 4.25MM-5.25MM X 18MM PROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 5.5MM POST DRILL STOP, 4.25MM-5.25MM X 8.5MM CONICAL EP® TWIST LOCK TM COPING MPLANT EP® PICK-UP COPING CERTAIN® EP® TWIST LOCK TM COPING Disposable Countersink Drill Index Coping - Surgical Disposable Pilot Drill CERTAIN® HEX TRY-IN SCREW CERTAIN® STRAIGHT PICK UP COPING CERTAIN® PICK-UP COPING Disposable Drill Kit Drill Kit Tapered CONICAL EP® PICK-UP COPING (HEXED) IMPLANT EP® TWIST LOCK TM COPING Disposable Round Drill Drill Kit Parallel Walled IMPLANT EP® PICK-UP COPING CERTAIN® STRAIGHT PICK-UP COPING Standard Abutment Transfer Coping Standard Abutment Pick-Up Coping CERTAIN® TWIST LOCK TM STRAIGHT TRANSFER COPING CONICAL EP® PICK-UP COPING (NON-HEXED) Disposable Twist Drill, Non-Hubbed Pick-Up Impression Coping Conical Abutment Pick-Up Coping Disposable Twist Drill PROVIDE® IMPRESSION COPING 4.8MM(P) - 4MM POST PROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 4MM POST DRILL STOP, 4.25MM-5.25MM X 13MM PROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 5.5MM POST DRILL STOP, 2.3MM-3.25MM X 10MM DRILL STOP, 2.3MM-3.25MM X 20MM PROVIDE® IMPRESSION COPING 6.5MM(P) - 4MM POST wire, guide, catheter HT PROTURN Guide Wire (Same as Powerturn, but sold in Japan) wire, guide, catheter HT POWERTURN Guide Wires (includes POWERTURN ULTRA and FLEX) AOC BONE WAX Ostene DuraFuse wire, guide, catheter TRAVERSE 14 Guide Wire stent, renal HERCULINK ELITE RENAL STENT SYSTEM, RX stent, renal HERCULINK ELITE PERIPHERAL STENT SYSTEM wire, guide, catheter BALANCE MIDDLEWEIGHT TREK (Japan only) wire, guide, catheter BALANCE TREK 14 Armada 35/35LL PTA Catheter wire, guide, catheter Hi-Torque CROSS-IT XT Guide Wires PROGENIX® PLUS filler, bone void, calcium compound ACCELL TBM ACCELL TBM ACCELL EVO3 (FORMERLY A2I) OSTEOSURGE 100 Trel-XPRESS 300 Prep-Tite® Cap barrier, synthetic, intraoral Straumann MembraGel catheter, biliary, diagnostic HERCULINK ELITE Biliary Stent System, RX NovaBone MacroFORM - MIS OsteoFlo OsteoFlo NanoPutty Tube 10cc OsteoFlo NanoPutty Tube 5cc OsteoFlo NanoPutty Syringe 10cc OsteoFlo NanoPutty Syringe 2.5cc OsteoFlo NanoPutty Syringe 1cc OsteoFlo NanoPutty Syringe 5cc wire, guide, catheter IRONMAN 14 Guide Wire wire, guide, catheter SPARTACORE 14 Guide Wire Macropore MX Mandibular Fixation System Macropore DX Distractor System AlloSync CB Putty & Pastev Dexcom ONE+ Continuous Glucose Monitoring System wire, guide, catheter PILOT Guide Wires Hi-Torque PILOT Guide Wires wire, guide, catheter REGISTA CONTEST (Japan only, ¿confidential¿) Surgical mesh OrthoWrap Bioresorbable Sheet OrthoWrap bone grafting material, human source ACCELL CONNEXUS ORTHOBLAST II DBM PUTTY & PASTE ORTHOBLAST II DBM PUTTY & PASTE, DYNABLAST PUTTY & PASTE Surgical mesh MacroPore Surgi-Wrap MAST Bioresorbable Sheet KA2210/25 KA2110/50 TRU-FIX Catheter Fixation Kit KA1224/50 KA2210/50 KA1154/25 KA2254/25 KA1124/100 KA2310W/25 KA2154/50 MTS003/100 KA2130/50 KA1124/25 Zip DS Dressing Shield Bandages KA1118/50 KA2211/25 KA1254/25 OPSITE, IV3000 Frame Delivery COVRSITE Plus OPSITE, IV3000 1-Hand Breg OPSITE, IV3000 1-Hand Ported OPSITE Post Op, IV 3000 OPSITE Flexigrid, IV3000 Standard Skin Fix OPSITE Flexigrid, IV3000 Ported Tape & Bandage, Adhesive - 004792,004793,004794,004795, 004796,002970,003008,003276, 004342,003175,004322,005121, 005001 Incise Film BAND-AID® Brand TOUGH STRIPS® Bandages TrialOn BAND-AID® Brand Flexible Fabric Bandages Tube Holder 100/case Tube Holder White Dressings (Breg) SureSeal Pressure Bandage Primapore CovRsite Enclose II wire, guide, catheter FLOPPY II 14 Surgical Mesh Hydrosorb Bioresorbable Surgical Mesh

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Device in the United States for Export Only