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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Large Plate/Wire Cutter - 00192896106772

LARGE PLATE/WIRE CUTTER HEAVY DUTY CUTS UP TO 3.5 MILLIMETERS MAXIMUM 9.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-104XQ
In Commercial Distribution

  • 00192896106772 ()

  • Length: 9.5 Inch


  • Orthopaedic implantable-device cutter

ClariCT.AI - 08800046800136

ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format regardless of the manufacturer of CT scanner or model. The original cleared device (K183460) is a software application to denoise on CT images, integrated with the clinical environment through DICOM communication on an on-premise environment, and runs under Microsoft Windows platform. The device consists of Denoise Processing module that denoises CT images and other modules (Window application module) that provide many features such as handling DICOM connection from/to PACS, user interface, worklist management and viewer. The subject device, ClariCT.AI, added a new module (named AI Marketplace Integration module) to the original cleared device (K183460) to enable installation on the AI Marketplace system. The module integrates the Denoising Processor of original device into the AI Marketplace system. ClariCT.AI, consists only of the AI Marketplace Integration Module and the Denoising Processor, can be installed in the AI Marketplace system that integrates centrally with PACS and seamlessly integrates into the existing IT and modality infrastructure. An AI Marketplace system, which can be integrated with the ClariCT.AI, is a cloud-based AI platform service that connects end users (e.g. hospitals, imaging centers) and AI medical imaging applications developed by third parties. These AI Marketplace systems provide many features such as handling DICOM connection from/to PACS, user interface, authentication, worklist control, and orchestrating third party AI applications. With the newly added module, ClariCT.AI will function as a software device integrated with such system, and therefore the responsibility of our software is bound to change so as to take care of only essential functionality such as denoising process and system interface.
ClariPI Inc.
1.3.3
In Commercial Distribution

  • 08800046800136 ()


  • Radiology DICOM image processing application software

Laryngoscopy Forceps - 00192896107731

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 Millimeters Cup Angled Up 45 Degrees Right Quantum
SONTEC INSTRUMENTS, INC.
1301-280Q
In Commercial Distribution

  • 00192896107731 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107694

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Angled Up 45 Degrees Left Quantum
SONTEC INSTRUMENTS, INC.
1301-232Q
In Commercial Distribution

  • 00192896107694 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107373

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 Millimeters Cup Angled Up 45 Degrees Left Quantum
SONTEC INSTRUMENTS, INC.
1301-282Q
In Commercial Distribution

  • 00192896107373 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107335

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Angled Up 45 Degrees Right Quantum
SONTEC INSTRUMENTS, INC.
1301-230Q
In Commercial Distribution

  • 00192896107335 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107052

LARYNGOSCOPY FORCEPS CONICAL TUBE 2 MILLIMETERS SHAFT 2.5 X 4 MILLIMETERS CUP POINTED UP-ANGLE RIGHT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-294Q
In Commercial Distribution

  • 00192896107052 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107038

LARYNGOSCOPY FORCEPS CONICAL TUBE 2 MILLIMETERS SHAFT 2.5 X 4 MILLIMETERS CUP POINTED UP-ANGLE LEFT QUANTUM
SONTEC INSTRUMENTS, INC.
1301-296Q
In Commercial Distribution

  • 00192896107038 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

WIRE END CUTTER - 00192896082571

WIRE END CUTTER DOUBLE ACTION TUNGSTEN CARBIDE CUTS WIRE UP TO 2.5 MILLIMETERS 8.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-100Q
In Commercial Distribution

  • 00192896082571 ()

  • Cuts Wire up to 2.5 Millimeter
  • Length: 8.5 Inch
1103-100Q

  • Orthopaedic implantable-device cutter

DaliaSense - 00860011532828

A Bluetooth blood pressure monitor compatible with the DaliaHealth platform, measuring heart rate, diastolic and systolic blood pressure, and an AI analysis for irregular heartbeats.
Stethoai LLC
1
In Commercial Distribution

  • 00860011532828 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Finochietto Baby Haight Retractor - 00192896115316

Finochietto Baby Haight Rib Spreader Retractor Child Size 1.125 x 1.125 Inches Extended Rack Stainless Steel Quantum
SONTEC INSTRUMENTS, INC.
2500-131LQ
In Commercial Distribution

  • 00192896115316 ()

  • Blade Spread 6 Inches
2500-131LQ

  • Rib spreader, reusable

Laryngoscopy Forceps - 00192896107748

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 X 4 Millimeters Cup Angled Up 45 Degrees Quantum
SONTEC INSTRUMENTS, INC.
1301-286Q
In Commercial Distribution

  • 00192896107748 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107021

LARYNGOSCOPY FORCEPS CONICAL TUBE 2 MILLIMETERS SHAFT 2.5 X 4 MILLIMETERS CUP POINTED UP-ANGLE 45 DEGREES QUANTUM
SONTEC INSTRUMENTS, INC.
1301-292Q
In Commercial Distribution

  • 00192896107021 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Wire End Cutter - 00192896105195

WIRE END CUTTER DOUBLE SPRING ACTION TUNGSTEN CARBIDE CUTS WIRE UP TO 1.5 MILLIMETERS 6.25 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-105Q
In Commercial Distribution

  • 00192896105195 ()

  • Length: 6.25 Inch


  • Orthopaedic implantable-device cutter

WIRE/PIN CUTTER - 00192896097179

WIRE/PIN CUTTER DOUBLE ACTION TUNGSTEN CARBIDE CUTS WIRE UP TO 2.2 MILLIMETERS 30 DEGREE ANGLE QUANTUM
SONTEC INSTRUMENTS, INC.
1103-103VQ
In Commercial Distribution

  • 00192896097179 ()

  • Cuts up to 2.2 Millimeters
  • Length: 8.75 Inch
  • 30 Degree Tip
1103-103VQ

  • Orthopaedic implantable-device cutter

STERNAL WIRE TWISTER NEEDLE HOLDER - 00192896051782

STERNAL WIRE TWISTER NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED BROAD 5 X 20 MILLIMETERS JAW 7.75 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-153Q
In Commercial Distribution

  • 00192896051782 ()

  • 5 x 20 Millimeter Jaw
  • Length: 7.75 Inch
1103-153Q

  • Suturing needle holder, reusable

STERNAL WIRE TWISTER NEEDLE HOLDER - 00192896051768

STERNAL WIRE TWISTER NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED BROAD 5 X 20 MILLIMETERS JAW 7.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1103-152Q
In Commercial Distribution

  • 00192896051768 ()

  • 5 x 20 Millimeter Tip
  • Length: 7 Inch
1103-152Q

  • Suturing needle holder, reusable

Quantum ® System M ® - 05060434420671

Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS1-130
In Commercial Distribution

  • 05060434420671 ()
51-000044-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420664

Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 1.3m
SPECTRUM MEDICAL LIMITED
HBS2-130
In Commercial Distribution

  • 05060434420664 ()
51-000043-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420657

Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS3-130
In Commercial Distribution

  • 05060434420657 ()
51-000042-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420640

Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS4-130
In Commercial Distribution

  • 05060434420640 ()
51-000041-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420633

Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m
SPECTRUM MEDICAL LIMITED
HBS1-200
In Commercial Distribution

  • 05060434420633 ()
51-000040-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420626

Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 2m
SPECTRUM MEDICAL LIMITED
HBS2-200
In Commercial Distribution

  • 05060434420626 ()
51-000039-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420619

Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 2m
SPECTRUM MEDICAL LIMITED
HBS3-200
In Commercial Distribution

  • 05060434420619 ()
51-000038-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420602

Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m
SPECTRUM MEDICAL LIMITED
HBS4-200
In Commercial Distribution

  • 05060434420602 ()
51-000037-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420138

Tube ID 1/2" x Wall 3/32" (OD 11/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420138 ()
H11XLD

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420121

Tube ID 3/8" x Wall 3/32" (OD 9/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420121 ()
H9XLM

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420114

Tube ID 1/4" x Wall 3/32" (OD 7/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420114 ()
H7XLH

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420107

Tube ID 1/4" x Wall 1/16" (OD 3/8")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420107 ()
H6XLE

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420091

Tube ID 3/16" x Wall 1/16" (OD 5/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420091 ()
H5XLA

  • Extracorporeal blood gas/pH monitor
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