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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2020-07-30 |
| Temporary Carotid Catheter For Embolic Capture | NTE | Class 2 | Cardiovascular | No | 2013-03-21 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2012-11-30 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2012-11-30 |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2024-10-22 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2019-10-24 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-25 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-25 |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | Class 2 | General, Plastic Surgery | No | 2012-11-30 |
| Biologic Material, Dental | NQA | Class 3 | Dental | No | 2012-11-29 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2019-10-25 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2012-11-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2012-11-29 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2019-10-25 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2015-06-29 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2019-10-24 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2012-11-29 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2013-03-22 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2013-02-25 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2013-02-25 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2012-11-29 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2024-02-09 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2012-11-30 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2019-12-06 |
| Sensor, Glucose, Invasive | MDS | Class 3 | Unknown | No | 2012-11-29 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-03-25 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2012-11-30 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2013-02-25 |
| Integrated Continuous Glucose Monitoring System For Professional Retrospective Use | QDL | Class 2 | Clinical Chemistry | No | 2021-05-18 |
| Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | QDK | Class 2 | Clinical Chemistry | No | 2021-05-18 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-10-21 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2015-10-07 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2013-03-22 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2018-03-22 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2012-11-30 |
| Prosthesis, Tracheal, Expandable, Polymeric | NYT | Class 2 | General, Plastic Surgery | No | 2024-10-21 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | Class 1 | General Hospital | No | 2018-03-21 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2012-11-29 |
| Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | QII | Class 2 | Clinical Chemistry | No | 2024-10-22 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2012-10-24 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2012-11-29 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2013-02-25 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2013-03-22 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2019-11-18 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2013-03-25 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2012-11-29 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2012-11-30 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
| Mesh, Surgical, Collagen, Diaphragmatic Hernia | OWV | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2013-03-21 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-03-15 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-07-13 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-07-13 |
| Collagen Corneal Shield | MOE | Class 1 | Ophthalmic | No | 2012-11-30 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2012-11-30 |
| Pericardial Patch To Facilitate Revision Surgeries | OMH | Class 2 | Cardiovascular | No | 2012-11-29 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2012-11-15 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2012-11-30 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2013-01-13 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2019-10-25 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2012-11-30 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2019-10-24 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2012-11-29 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2019-10-25 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2012-11-01 |
| Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant | PNW | Class 3 | Unknown | No | 2017-10-11 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2012-11-01 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2012-11-29 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2012-11-29 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2012-11-29 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2019-10-25 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2013-03-22 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2012-11-27 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-02-04 |
| Absorbable Coronary Drug-Eluting Stent | PNY | Class 3 | Unknown | No | 2016-07-07 |
| Pulmonary Valve Prosthesis Percutaneously Delivered | NPV | Class f | Unknown | No | 2023-01-27 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2012-11-09 |
| Wax, Bone | MTJ | Class U | Unknown | No | 2012-11-30 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2023-03-21 |
| Stent, Renal | NIN | Class 3 | Unknown | No | 2013-03-22 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2013-05-07 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2012-11-29 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2013-02-25 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2021-02-09 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2021-02-09 |
| Scaffold, Infrapopliteal, Absorbable | NXW | Class 3 | Unknown | No | 2024-10-24 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2012-11-12 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2012-11-12 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2024-10-21 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2019-10-25 |
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