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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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CAPTION HEALTH, INC.
Alastor
In Commercial Distribution

  • 00860003586341 ()


  • Ultrasound imaging system application software
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
In Commercial Distribution

511-00019

  • Ultrasound imaging system application software
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.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software
Straight, Rotatable, with Insulated, Non Locking HF Handle, Flush Port
Surgical Direct, Inc.
SD145592B
In Commercial Distribution

  • B382SD145592B0 ()
SD145592B

  • Flexible endoscopic tissue manipulation forceps, single-use
BLUNT F/TAP/FEN HF PANO SCP SHTH W/HDLE
ARTHREX, INC.
AR-3375-4204
In Commercial Distribution

  • 00888867431324 ()
AR-3375-4204

  • Orthopaedic trocar blade, reusable
TROCAR F/ TAP/FEN,HF PANO SCP SHTH W/HDL
ARTHREX, INC.
AR-3375-4202
In Commercial Distribution

  • 00888867431300 ()
AR-3375-4202

  • Laparoscopic trocar blade, reusable
BLUNT F/TAP/FEN HF 4MM SCP SHTH W/HDLE
ARTHREX, INC.
AR-3375-4004
In Commercial Distribution

  • 00888867030442 ()
AR-3375-4004

  • Endoscope sheath, reusable
TROCAR F/ TAP/FEN,HF 4MM SCP SHTH W/HDLE
ARTHREX, INC.
AR-3375-4002
In Commercial Distribution

  • 00888867030404 ()
AR-3375-4002

  • Endoscope sheath, reusable
CANN OBT F/TAP/FEN HF 4mm STORZ SCP SHTH
ARTHREX, INC.
AR-3323
In Commercial Distribution

  • 00888867029514 ()
AR-3323

  • Rigid endoscope obturator
CON OBTU,F/TAP/FEN HF 4mm STORZ SCP SHTH
ARTHREX, INC.
AR-3321
In Commercial Distribution

  • 00888867029491 ()
AR-3321

  • Rigid endoscope obturator
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