Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1724474

FEI Number

3003094851

Entity Name

Terumo BCT STERILIZATION SERVICES, Inc.

City/State/Country

LAKEWOOD, CO, US

Establishment Address

11308 W Collins Ave, LAKEWOOD, CO 80215, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Terumo BCT, INC. (Owner Number: 9002708)

Owner / Operator Contact Address

10811 WEST COLLINS AVE., --, Lakewood, CO 80215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Merit HeRO Graft Merit Pursue Microcatheter Byrd Dilator Sheath Set SCD391 Sonicision¿ Cordless Ultrasonic Dissector SCD396 Sonicision¿ Cordless Ultrasonic Dissector SCT12 Sonicision¿ Torque Wrench Stylette (rob obturator) Cardioplegia Pack Cardioplegia System Perfusion Pack K10 Waste Management Kit 7 Fr TURBO BOOSTER 8 Fr TURBO BOOSTER Wrapsody Cell-Impermeable Endoprosthesis PreludeEASE Hydrophilic Sheath Introducer, 4F-6F Merit PAK Viceroy Inflation Device Merit Pressure Monitoring Tubing Exite Contrast Injection Line "Merit High Pressure Tubing Merit Convenience Kits PinVise Guide Wire Torque Device Contamination Sleeve Transvalvular Insertion Tool (TVI) Worley Slitter Cutter Lead Clippers Bulldog Lead Extender Retrograde Cardioplegia Cannula SecureLoc Safety Needle 80mm Balloon Length Resilience Fully Covered Esophageal Stent System Cuff Implantor Prelude Sheath Introducer Prelude Sheath Half Size (ACT) Venclose Mister E2512H Rocker Switch Pencil, Insulated Angled Blade Electrode, Holster E2511H Rocker Switch Pencil, Insulated Hook Electrode, 45 Degree Angle, Holster E2510H Rocker Switch Pencil, Insulated Hook Electrode, 90 Degree Angle, Holster E2515H Rocker Switch Pencil, Blade Electrode, Holster Elation5 Wireguided Balloon Elation5 Fixed Wire Balloon Elation Fixed Wire Balloon Vein Irrigation Cannula Repositional Chest Tube Plastic Billary Stent Kit "Plastic Biliary Stent Input SSV Split Sheath Introducer Kit with Valve, et. al. Safe Sheath Classic Sheath AEROmini Tracheobronchial Stent System Diamond TOUCH Inflation Device and Fluid Dispensing Syringe Flex Neck Infant Catheter Drainage Tubing Ventrax Delivery System ER2 Saturate Mixing Systems LF1212A LigaSure¿ Curved, Small Jaw, Open Sealer/Divider Arcadia Balloon Catheter HeRO Graft Port Saver Merit Triboglide Syringe Merit HeRO Graft ACT1020 COOLTIP RFA Single Electrode Kit 10X2 ACT1030 COOLTIP RFA Single Electrode Kit 10X3 ACT530 COOLTIP RFA Single Electrode Kit 15X3 ACT1510 COOLTIP RFA Single Electrode Kit 15X1 SWCT1530 RFA Two Electrodes Kit SWCT1530 ACT1507 COOLTIP RFA Single Electrode Kit 15X0.7 SWCT15303 RFA Switching Electrode Kit SWCT15303 ACT1520 COOLTIP RFA Single Electrode Kit 15X2 SWCT2530 RFA Switching Electrode Kit SWCT2530 SWCT1540 RFA Switching Electrode Kit SWCT1540 ACTC1025 COOLTIP RFA Cluster Electrode Kit 10X2.5 ACTC1525 COOLTIP RFA Cluster Electrode Kit 15X2.5 SWCT25303 RFA Switching Electrode Kit SWCT25303 SWCT2540 RFA Switching Electrode Kit SWCT2540 ACT2030 COOLTIP RFA Single Electrode Kit 20X3 ACT2020 COOLTIP RFA Single Electrode Kit 20X2 ACT2530 COOLTIP RFA Single Electrode Kit 25X3 ACTC2025 COOLTIP RFA Cluster Electrode 20X2.5 KIT Flex Neck Catheter "Introducer Needle with Trocar Stylet 2mm 6Fr. Turbo-Power OTW, Manual 2.3mm 7Fr. Turbo-Power OTW, Manual Fountain Catheter and Occluding wire HeRo Graft TightRail, 11F TightRail, 9F TightRail Mini, 9F TIghtRail Mini, 11F TightRail, 13F 7 Fr TURBO TANDEM PreludeEASE Hydrophilic Sheath Introducer, 7F EasyFlow Duo Cannula Trifurcated Fluid Transfer Tube Set Bifurcated Fluid Transfer Tube Set Laureate Hydrophilic Guide Wire Nexus NIS® IV Plus® 8 Fr TURBO TANDEM "Safety Paracentesis Tray ReSolve Non-Locking Drainage Catheter One-Step Centesis Catheter ReSolve Locking Drainage Catheter FastBreak Connector Honor Hemostasis Valve basixCOMPAK Inflation Device BIG60 ALPHA Inflation Device basixTOUCH Arcadia High Pressure Inflation Syringe (IN55KVCF, IN55VCF) basixTAU basixTOUCH40 Inflation Syringe basixSKY Inflation Device MYSHELL Hemostasis Valve Rotating Adaptor H2O Torque Device Stopcock One Port Manifold Merit Manifold Merit Marquis Stopcock, One-port Manifold Merit Drainage Depot Medallion Syringe K02 Syringe Kit (multiple K01) K01 Syringe Kit (MSS) AERO Tracheo Stent and Delivery System Corvocet Biopsy System Nexus NIS® LLD E (3 pk) ArgoTrans Pressure Infusor Bag (PIB) SCOUT and SCOUT Check Consoles SCOUT Reflector and Delivery System SCOUT Handpieces & Surgical Guides DriPAD Super Absorbent Pad Blue Diamond Inflation Syringe Monarch Compak Inflation Syringe Worley Impress Angiographic Catheter EZ (3 pk) LLD EZ Single Pack MAXXWIRE K08 Fluid Management Kit K04 Tubing Kit EM600 Vented Adapter 0.2 Micron Venting Pin Flex Neck Extender/Repair Kit Peritoneal Dialysis Catheter connector Nexus NIS® E1455B-4 Edge Coated Blade Extended Electrode, Insulated, Sleeve, 4" E1455B Edge Coated Blade Electrode, Insulated, Sleeve, 2.75" E1465B Edge Coated Needle Electrode, Insulated, Sleeve, 2.84" E1465-6 Edge Coated Needle Extended Electrode, Insulated, 6" E1465 Edge Coated Needle Electrode, Insulated, 2.84" E1455-6 Edge Coated Blade Extended Electrode, Insulated, 6¿ E1455-4 Edge Coated Blade Electrode, Insulated, 4" E1465B-4 Edge Coated Needle Extended Electrode, Insulated, Sleeve, 4" E1465-4 Edge Coated Needle Extended Electrode, Insulated, 4" E2782R-28ASP E2784R-28ASP E2783R-28ASP E2781R-28ASP E2783R-36ASP K16 Microcatheter Kit ASAPLP Embolectomy Catheter ReSolve Biliary Locking Drainage Catheter purAFi Arterial Filter Thoracic Catheter Saturation-Hematocrit Monitor and Sensor Centros/CentrosFLO Liberator Beacon Tip Locking Stylet "Cardioplegia Pack Micro-Volume Inlet (w/Large Bore Spike) Bag Adapter Needle Port Adapter Internal Thread (European) Needle Port Adapter External Thread MicroMacro¿ Replacement Pump Tube Set Non-Vented High-Volume Inlet Extension, External Thread (TPN Set) Vented High-Volume Inlet (MM12/23) PAL (Pen and Label) Family VTS1737PCK Planar Coagulation MW Ablation Kit VT2237 Evident MW Ablation Percutaneous VT1737 Evident MW Ablation Percutaneous Antenna, 17 cm ProGuide Long Term Hemodialysis Catheter Softouch Diagnostic Intra Cath. with Vessel Vessel Sizing Catheter (VSC) Luer Lock Universal Spike Tube Set Extension Piece Fluid Transfer Tube Set with Vented Spike 0.2 Micron Filter Attachment Manual Gel Bags Fluid Transfer Tube Set Top Fill Bags Bag Adapter Internal-to-External Thread Bag Adapter External-to Internal Thread Vented Micro-Volume Inlet (MM12/23) Low Prime-Volume Fluid Transfer Tube Set Gravity Mixing Set Finale Vascular Compression Device MAP Torque Device and Guide Wire Introducer Fountain ValveTip Infusion Catheter Continuous Flush Device SMARTxT Tubing Perfusion Packs Connectors IV Plus® GO2WIRE Guide Wire EasyFlow Aortic Cannula LF5544 LigaSure¿ Advance Monopolar Tip Laparoscopic Sealer/Divider Pistol Grip 5mm-44cm Alimaxx-B Prelude Choice Hemostasis Valve Adapter Merit Marquis Flow Switch Check Valve Stopcock one port manifold Hemostasis Valve Adapter H20 Torque Device MYSHELL Hemostatic Valve Merit Marquis Stopcock Rotating Adapter Merit Manifold 10Fore Hemostasis Valve (stand-alone) IV Plus® SureCross Support Catheter Resolve Biliary Locking Drainage Catheter Meritrans Disposable Transducer Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Violet)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Green)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Fluorescent Red)) Terumo Disposable Hypodermic Syringe (Bandolier Syringe Strip) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Gray)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Blue)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Yellow)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Orange)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (Salmon)) Terumo Disposable Hypodermic Syringe (RapidFill Syringe Strip (White)) Acuity Universal Cutter Pressure Monitoring Line Perfusion Adapter TRAM-P TRAM VacLok AT Syringe LLD #2 LEAD CUTTER LLD ACCESSORY KIT LLD #1 (3 pk) LLD #3 LLD #3 (3 pk) LLD #2 (3 pk) LLD #1 FEP Catheter True Form Reshapable Guide Wire Nexus TKO® Merit Contrast Management System 035" QUICK CROSS SELECT 135CM ANGLED, BOX OF 5 035" QUICK CROSS EXTREME 135CM STRAIGHT, BOX OF 5 035" QUICK CROSS SELECT 90CM ANGLED, BOX OF 5 035" QUICK CROSS EXTREME 65CM STRAIGHT, BOX OF 5 035" QUICK CROSS SELECT 150CM ANGLED, BOX OF 5 035" QUICK CROSS SELECT 65CM ANGLED, BOX OF 5 035" QUICK CROSS EXTREME 90CM STRAIGHT, BOX OF 5 035" QUICK CROSS EXTREME 150CM STRAIGHT, BOX OF 5 BioSentry Sealan System Vasco Loop TIghtRail Sub-C, 11F TIghtRail Sub-C, 9F TightRail Sub-C, 13F Prelude Sheath Introducer Rika Plasma Separation Set Rika Plasma Donation System Rika Plasma Bottle 1.7 OTW TURBO ELITE 1.4 OTW TURBO ELITE 2 RX TURBO ELITE 1.7 RX TURBO ELITE 2.3 OTW TURBO ELITE 1.4 RX TURBO ELITE 0.9 OTW TURBO ELITE 2.5 OTW TURBO ELITE 2 OTW TURBO ELITE 0.9 RX TURBO ELITE Corvocet Biopsy System StabiliT Bone Cement and Saturate Mixing System Vascular Dilator Kit KanguruWeb Intellisystem Inflation Device Fluid Dispensing Syringe "Rotating Adapter, Male-Female Monarch AP Merit Marquis Flow Switch Vessel Dilator BowTie Wire Insertion Device Faller Trocar purAFi HA Arterial Filter Ventrax Delivery System Performa Diagnostic Intravascular Catheters BRAT 2 System and Accessories ASAP Catheter Braided Guiding Introducer EZ Cross Introducer, et. al. HeartSpan Fixed Curve Braided Transseptal Sheath CardiaGuide Fixed Curve Braided Trasseptal Sheath Air Aspirator Vessel Cannula Aortic Cannula Perfusion Adapter K13 Label Kit K05T - Inflation Kit K12T - Procedure Kit K19 Combination Packs K05 Inflation Kit 10Fore Hemostasis Valve (MAP) K23C Vein Accessory Kit K12 (Procedure Kit) K22C Vein Tray Smart Tip Control Syringe 014" QUICK CROSS SELECT 150CM ANGLED, BOX OF 5 018" QUICK CROSS SELECT 135CM ANGLED, BOX OF 5 018" QUICK CROSS EXTREME90CM STRAIGHT, BOX OF 5 018" QUICK CROSS EXTREME 150CM STRAIGHT, BOX OF 5 014" QUICK CROSS EXTREME 150CM STRAIGHT, BOX OF 5 018" QUICK CROSS EXTREME 135CM STRAIGHT, BOX OF 5 018" QUICK CROSS SELECT 150CM ANGLED, BOX OF 5 014" QUICK CROSS SELECT 135CM ANGLED, BOX OF 5 014" QUICK CROSS EXTREME 135CM STRAIGHT, BOX OF 5 018" QUICK CROSS SELECT 90CM ANGLED, BOX OF 5 Merit Disposal Depot Cardioplegia Adaptor SCCA ReSolve CirQ Nephrostomy Catheter Merit Monarch Prelude Short Sheath Introducer Aspira Peritoneal Drainage System 13F Long Dilator Sheath Set 11.5F Long Dilator Sheath Set 10F Dilator sheath Set 10F Long Dilator Sheath Set 13F Dilator Sheath Set 8.5F Long Dilator Sheath Set 8.5F Dilator Sheath Set 11.5F Dilator Sheath Set BiPolar Hemostatic Probe Laproscopic Peritoneal Dialysis Catheter Implantation System (VP-411) Percutaneous Peritoneal Dialysis Catheter Implantation System (VP-511, VP-511M) Peritoneoscopic or Laproscopic Peritoneal Dialysis Catheter Implantation System (VP-210, VP-211) Impress with Legato Hydrophilic Coating AEROmini Tracheobronchial Stent System 035" QCE 65CM Straight, Box of 5 035" QCS 135CM Angled, Box of 5 035" QCE 90CM Straight, Box of 5 035" QCE 150CM Straight, Box of 5 014" QCE 150CM Straight, Box of 5 014" QCS 135CM Angled, Box of 5 018" QCE 135CM Straight, Box of 5 035" QCS 90CM Angled, Box of 5 014" QCS 150CM Angled, Box of 5 035" QCE 135CM Straight, Box of 5 014" QCE 135CM Straight, Box of 5 035" QCS 150CM Angled, Box of 5 018" QCS 135CM Angled, Box of 5 018" QCE 150CM Straight, Box of 5 018" QCS 90CM Angled, Box of 5 035" QCS 65CM Angled, Box of 5 018" QCE 90CM Straight, Box of 5 018" QCS 150CM Angled, Box of 5 AERO DV Tracheobronchial Stent System Medallion IZOFF Syringe Closed Waste Basin ShortStop GrandStand Temporary Sharps Holder BackStop Plus Closed Waste Basin ShortStop Temporary Sharps Holder ShortStop Advantage Temporary Sharps Holder MiniStop Plus Closed Waste Basin K11 Pressure Monitoring Kit K09 Manifold Kit K17 Interventional Kit Prelude SNAP Splittable Sheath Introducer Access -9 / Access Plus / Passage SPINR High-Performance Guidewire Catheter Monarch Syringe Fluid Dispense System In-Line Hemostasis Valve FLO30 Merit Ideal 9F Hydrophilic Sheath Introducer Miser Contrast Management System Orthofuser Wound Drainage/Autotransfusion System RapidFill Connectors (Blue) Tube Set, StdVol, Biurc, St, Luer Lock-to-Bag-Adapter Internal Thread (European) Luer Lock-to-Bag-Adapter Tube Set, StdVol, Trifurc, St, Fluid Transfer Extension Set (Male Connectors) Dispensing Pin Fluid Transfer Tube Set without Vented Spike RapidFill Connectors (Green) RapidFill Connectors (Red) Fluid Transfer Extension Set (Male - Female Connectors) IV Plus® E2530-6 Argon Plus Flexible Electrode, Coag Only, 6" E2530-28 Argon Plus Laparoscopic Flexible Electrode, Coag Only, 11" E2530-3 Argon Plus Flexible Electrode, Coag Only, 3 Worley Advanced CSG Worley Advanced LVI Lateral Vein Introducers, et. al. SafeSheath CSG Introducer Sheath Kit Elation Pulmonary Balloon PreludeSYNC EZ Radial Compression Device Cannulation Tourniquet IV Plus® Coronary Control Syringe K07 Syringe Kit (multiple K06) K06 Syringe Kit (single CCS) E2580-28 Argon Plus Laparoscopic Blade Electrode, Retractable, 11" E2583-28 Argon Plus Laparoscopic Tungsten Blunt Needle Electrode, Retractable, 11" E2582-28 Argon Plus Laparoscopic Tungsten Sharp Needle Electrode, Retractable, 11" E2581-28 Argon Plus Laparoscopic Modified Flat-L Electrode, Retractable, 11" Brighton Bipolar Probe 5.5F Worley Advanced LVI Lateral Vein Introducer TORQMAX SHEATH GRIP ACCESSORY Merit Administration Set IV Plus® PreludeSYNC Distal Radial Compression Device PreludeSYNC Radial compression Device Pinvise Torque Device SeaDragon Torque Device SPINR High-Performance Guidewire Catheter Insufflation Set MiniStop Filter Closed Waste Basin High Pressure Connector Tubing ASAP Aspiration Catheter ASAPLP Aspiration Catheter FlowGuard BRC-BAL-INT-FL/A K20 Endoscopic Kit K20T - Endoscopic Kit Tenmo Elite Biopsy System Squirt Fluid Delivery System Vacuum Relief Check Valve 0.9 VITESSE, 80/80 ELCA 0.9 EXTREME, 80/80 ELCA 2 VITESSE-COS ELCA 1.4 VITESSE-COS ELCA 1.7 VITESSE-COS 20 mL Piston Syringe Exxtended Catheter Syringe Inlet Non-Vented High-Volume Inlet Vented Micro-Volume Inlet Vented High-Volume Inlet Furtura Saftey Scalpel Merit 1mL Syringe (COP) 2.3 OTW Turbo-Elite, OUS 2 RX Turbo-Elite 0.9 OTW Turbo-Elite 2.3 OTW Turbo-Elite 2.5 OTW Turbo-Elite 1.7 RX Turbo-Elite 2.3 OTW Turbo-Elite, US 1.7 OTW Turbo-Elite 2 OTW Turbo-Elite 2.5 OTW Turbo-Elite, US 0.9 RX Turbo-Elite 1.4 RX Turbo-Elite 2.5 OTW Turbo-Elite, OUS 1.4 OTW Turbo-Elite SwiftNINJA Microcatheter Continuous Flush Device VISISHEATH SIZE M SHORT VISISHEATH SIZE S LONG VISISHEATH SIZE L SHORT VISISHEATH SIZE M LONG VISISHEATH SIZE L MEDIUM VISISHEATH SIZE S SHORT VISISHEATH SIZE M MEDIUM VISISHEATH SIZE S MEDIUM VISISHEATH SIZE L LONG Merit Manifold Non-vascular Tissue Dilator Concierge Guiding Catheter RXP (Rapid Exchange Flushing Syringe) Prelude Prestige Splittable Sheath Introducer "Prelude Sheath Introducer SCOUT MD Guides SCOUT DM Console SCOUT MD Single-use Handpieces SCOUT MD Delivery System Hydrophilic Guidewire (Lake Region, 6676-G1, 6676-H1) Ostial Pro Stent Positioning System Micro Ace Gold Advanced Micro Access System K14 Dialysis Kit Squirt Fluid Delivery System Slip-Not X-Change Cement Dispensing Syringe Purge Assist Hydraulic-Master Syringe Assembly StabiliT Cement Delivery Syringe Master Syringe Assembly Hydraulic Assembly DiamondTouch Syringe Osseoflex Bone Filler Device (BFD) LF1544 LigaSure Blunt Tip Laparoscopic Sealer / Divider 5-44 Fountain Infusion System Nexus TKO® 14F CavaClear 16F CavaClear IV Plus® Nexus TKO® Nexus NIS®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-12-20
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2021-12-20
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2021-12-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-12-20
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-03-27
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2013-02-13
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2020-08-17
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2013-02-13
PPD	Universal Drainage Tray	Gastroenterology, Urology	Class 2	876.5130	2024-06-05
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2013-02-13
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	Unknown	Class 3	N/A	2025-01-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-01-28
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2013-02-14
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2013-02-14
OJV	Single Use Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2024-06-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2020-05-05
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-02-14
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2024-06-27
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2025-07-28
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2016-01-28
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-02-14
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2016-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2021-12-20
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2021-12-20
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-05-05
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2016-01-28
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2016-08-09
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-08-09
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-01-28
PYC	Paracentesis Tray	General, Plastic Surgery	Class 1	878.4200	2024-12-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-02-10
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2021-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
HXG	Tamp	Orthopedic	Class 1	888.4540	2021-12-20
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-12-20
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-12-20
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2021-12-20
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2021-12-20
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-12-20
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-02-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-01-16
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2021-12-20
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2021-12-20
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2021-12-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-01-28
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2013-02-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-06-27
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2013-02-14
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2022-08-16
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2022-08-16
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2022-08-16
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-06-27
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2013-02-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-02-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-01-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-02-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-14
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-03-17
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2013-02-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-02-13
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2013-02-14
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2013-02-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-14
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2020-08-17
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2013-02-14
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2024-05-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-02-08
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2016-01-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-12-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2013-02-13
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2021-12-20
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2024-05-21
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-03-01
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-01-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-02-14
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2013-02-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-01-28
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2024-06-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-02-14
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2024-06-05
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-02-13
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-01-28
FKO	Catheter, Peritoneal Dialysis, Single Use	Gastroenterology, Urology	Class 2	876.5630	2016-01-28
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
OWL	Peripheral Catheter Insertion Kit	General Hospital	Class 2	880.5200	2024-06-05
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2016-01-28
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2016-01-28
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2013-02-13
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2016-02-26
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	2016-02-26
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-02-14
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2026-03-04
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-02-13
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-02-13
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2013-02-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-02-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-01-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-02-13
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2013-02-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-14
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-17
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2013-02-14
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2013-02-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-12-20
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-02-14
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2021-12-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-01-28
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-02-14
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2013-02-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-11-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-12-20
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2013-02-14
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2013-02-14
PUR	Vacuum Syringe	General Hospital	Class 2	880.5860	2021-12-20
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2013-02-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-06-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-12-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-02-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-02-13
OMT	Absorbable Lung Biopsy Plug	General, Plastic Surgery	Class 2	878.4755	2024-03-29
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-02-26
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-06-27
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2016-01-28
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2022-06-16
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2013-02-13
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-03-28
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-12-20
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2016-02-26
FWW	Table, Operating-Room, Pneumatic	General, Plastic Surgery	Class 1	878.4960	2013-02-14
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-02-14
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2013-02-14
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2013-02-14
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-02-14
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2016-01-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-14
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-01-28
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2013-02-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-02-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-01-28
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2013-01-28
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2013-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-05-05
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2024-06-05
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2024-06-05
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-02-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-02-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-02-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2021-12-20
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2013-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-02-14
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2024-06-04
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-06-27
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-02-14
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2016-01-28
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-01-28
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2024-05-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-06-27
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2016-01-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-12-20
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-02-14
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2024-06-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-05-05
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2013-02-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-12-20
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2013-02-14
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2013-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-01-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-02-14
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2013-02-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-02-13
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2025-03-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-05-05
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2016-09-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2021-12-20
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2016-02-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2017-06-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-02-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-05-05
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2013-02-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-02-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2021-12-20
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2021-12-20
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2016-01-28
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2016-01-28
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2016-08-09
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2022-03-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-01-28
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2024-06-05
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-12-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2013-02-14
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	Cardiovascular	Class 2	870.4400	2013-02-13
LPC	Device, Angioplasty, Laser, Coronary	Unknown	Class 3	N/A	2013-02-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-02-14
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2016-01-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2013-02-13
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2013-02-13
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-02-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-12-20
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-06-27
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2016-11-09
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2021-12-20
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-02-13
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2013-02-14
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-05-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-01-28
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2013-02-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-05-05
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-02-14
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-11-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-01-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-02-14
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-01-23
PEV	Dialysis Administration Kit	Gastroenterology, Urology	Class 2	876.5820	2024-06-05
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2016-11-09
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2016-01-28
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2016-01-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-13
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2013-02-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Cardiovascular	Class 2	870.5125	2024-06-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-17

Official Correspondent

Corrine Lucas

US Agent Details

No US Agent registered (Local establishment).

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Terumo BCT, INC.

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3010425916	Terumo BCT Europe N.V.	Leuven Vlaams Brabant, BE
3011720361	Terumo BCT Vietnam Co., Ltd.	Binh An commune Dong Nai, VN
1722028	Terumo BCT, Inc..	Lakewood, CO, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1724474. Last updated year: 2026. Please use registration number 1724474 when referencing this establishment in official correspondence.