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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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SONTEC OLSEN-HEGAR NEEDLE HOLDER - 00192896088528

SONTEC OLSEN-HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP 6.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-108Q
In Commercial Distribution

  • 00192896088528 ()

  • Length: 6.5 Inch
1100-108Q

  • Suturing needle holder, reusable

Brown Adson Tissue Forceps - 00192896105447

BROWN ADSON TISSUE FORCEPS SERRATED HANDLE 7 X 7 TEETH QUANTUM
SONTEC INSTRUMENTS, INC.
136-688SQ
In Commercial Distribution

  • 00192896105447 ()

  • Length: 4.75 Inch


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Stevens Tenotomy Scissors - 00192896104082

STEVENS TENOTOMY SCISSORS POWER CUT GOLD SHORT TIP STRAIGHT BLUNT QUANTUM
SONTEC INSTRUMENTS, INC.
1200-050Q
In Commercial Distribution

  • 00192896104082 ()

  • Length: 4.125 Inch


  • Nasal scissors

QUANTUM™ CT Overlay - 10841962111000

QUANTUM CT Overlay for Canon Aquilion CT for 244cm long cradle
Qfix
RT-4550TAQ2
In Commercial Distribution

  • 10841962111000 ()

  • Length: 244 Centimeter
RT-4550TAQ2

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962109076

QUANTUM CT Overlay for Toshiba Aquilion CT For 215cm long cradle
Qfix
RT-4550TAQ
In Commercial Distribution

  • 10841962109076 ()

  • Length: 215 Centimeter
RT-4550TAQ

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962109021

QUANTUM CT Overlay for Phillips Brilliance CT For 250cm long cradle
Qfix
RT-4550PBR
In Commercial Distribution

  • 10841962109021 ()

  • Length: 250 Centimeter
RT-4550PBR

  • Indexed-immobilization patient positioning system

16 Ch AI BREAST COIL 1.5T - 04260487680034

No Description
RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency

PowerLook AI Mammo Container 1.0.0 Blackford - 00850008977534

No Description
Icad, Inc.
DSC036-01
In Commercial Distribution

  • 00850008977534 ()


  • Radiology DICOM image processing application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586341

No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586310

Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
Not in Commercial Distribution

511-00019

  • Ultrasound imaging system application software
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