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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 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

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586303

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

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

16 Ch AI BREAST COIL 1.5T - 04260487680034

No Description
RAPID Biomedical GmbH
10185781 02
In Commercial Distribution

  • 04260487680034 ()


  • MRI system coil, radio-frequency

K-ASSAY® Apo AI / B Control - 00816426021648

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-4M
In Commercial Distribution

  • 00816426021648 ()
K310C-4M

  • Multiple apolipoprotein IVD, control

K-ASSAY® Apo AI / B Control - 00816426021631

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-2M
Not in Commercial Distribution

  • 00816426021631 ()
K310C-2M

  • Multiple apolipoprotein IVD, control

QUANTUM™ CT Overlay - 10841962109045

QUANTUM CT for Somatom Emotion Duo, Esprit +, CT For 217cm long cradle
Qfix
RT-4550SS2
In Commercial Distribution

  • 10841962109045 ()

  • Length: 217 Centimeter
RT-4550SS2

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962108888

QUANTUM CT Overlay for GE HiSpeed CT For 219 cm long cradle
Qfix
RT-4550GEH
In Commercial Distribution

  • 10841962108888 ()

  • Length: 219 Centimeter
RT-4550GEH

  • Indexed-immobilization patient positioning system

METZENBAUM SCISSORS - 00192896098039

METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE SERRATED BLADE POWER CUT GOLD/BLACK QUANTUM
SONTEC INSTRUMENTS, INC.
1200-510Q
In Commercial Distribution

  • 00192896098039 ()

  • Length: 5.75 Inch
1200-510Q

  • General-purpose surgical scissors, reusable

METZENBAUM SCISSORS - 00192896098022

METZENBAUM SCISSORS STRAIGHT TUNGSTEN CARBIDE SERRATED BLADE POWER CUT GOLD/BLACK QUANTUM
SONTEC INSTRUMENTS, INC.
1200-505Q
In Commercial Distribution

  • 00192896098022 ()

  • Length: 5.75 Inch
1200-505Q

  • General-purpose surgical scissors, reusable

KNOWLES BANDAGE SCISSORS - 00192896097827

KNOWLES BANDAGE SCISSORS LEFT HANDED ANGLED SERRATED BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-190LQ
In Commercial Distribution

  • 00192896097827 ()

  • Length: 5.5 Inch
1200-190LQ

  • Bandage scissors, reusable

ROCHESTER CARMALT FORCEPS - 00192896094567

ROCHESTER CARMALT FORCEPS LONG SERRATED WITH HATCH TIP STR 6.25 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-150Q
In Commercial Distribution

  • 00192896094567 ()

  • Length: 6.25 Inch
1100-150Q

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

ROCHESTER CARMALT FORCEPS - 00192896094475

ROCHESTER CARMALT FORCEPS LONG SERRATED WITH HATCH TIP CURVED 6.25 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-152Q
In Commercial Distribution

  • 00192896094475 ()

  • Length: 6.25 Inch
1100-152Q

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

MICRO ALLIGATOR FORCEPS - 00192896092198

MICRO ALLIGATOR FORCEPS DELICATE CURVED LEFT SERRATED TIP BLACK ANODIZED COATED QUANTUM
SONTEC INSTRUMENTS, INC.
469-048BQ
In Commercial Distribution

  • 00192896092198 ()
469-048BQ

  • Surgical soft-tissue manipulation forceps, alligator, reusable

Stevens Tenotomy Scissors - 00192896106291

STEVENS TENOTOMY SCISSORS TUNGSTEN CARBIDE POWER CUT STRAIGHT POINTED SHARP BLADES QUANTUM
SONTEC INSTRUMENTS, INC.
1200-490Q
In Commercial Distribution

  • 00192896106291 ()

  • Length: 4.5 Inch


  • Tenotome

Forceps - 00192896103603

ROCHESTER CARMALT FORCEPS LONG SERRATED WITH HATCH TIP STRAIGHT 8.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-151Q
In Commercial Distribution

  • 00192896103603 ()

  • Length: 8 Inch


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

SONTEC OLSEN HEGAR NEEDLE HOLDER - 00192896094550

SONTEC OLSEN HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP 5.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-106Q
In Commercial Distribution

  • 00192896094550 ()

  • Length: 5.5 Inch
1100-106Q

  • Suturing needle holder, reusable

MICRO ALLIGATOR FORCEPS - 00192896092204

MICRO ALLIGATOR FORCEPS DELICATE CURVED RIGHT SERRATED TIP BLACK ANODIZED COATED QUANTUM
SONTEC INSTRUMENTS, INC.
469-050BQ
In Commercial Distribution

  • 00192896092204 ()
469-050BQ

  • Surgical soft-tissue manipulation forceps, alligator, reusable

SONTEC MAYO HEGAR NEEDLE HOLDER - 00192896051461

SONTEC MAYO HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP 6.25 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-113Q
In Commercial Distribution

  • 00192896051461 ()

  • Length: 6.25 Inch
1100-113Q

  • Suturing needle holder, reusable

Stratte Needle Holder - 00192896117495

Stratte Needle Holder Right Angled Tungsten Carbide Serrated Tip Light Weight Quantum
SONTEC INSTRUMENTS, INC.
2300-489RQ
In Commercial Distribution

  • 00192896117495 ()

  • Length: 10 Inch
2300-489RQ

  • Suturing needle holder, reusable

Knight Nasal Scissors - 00192896111677

Knight Nasal Scissors Serrated Power Cut Gold Right Curved 7.0 Inches Quantum
SONTEC INSTRUMENTS, INC.
475-306Q
In Commercial Distribution

  • 00192896111677 ()

  • Length: 7 Inch


  • Nasal scissors

Stevens Saberback Tenotomy Scissors - 00192896109759

Stevens Saberback Tenotomy Scissors Pointed Tips Tungsten Carbide Power Cut Curved Quantum
SONTEC INSTRUMENTS, INC.
2400-367Q
In Commercial Distribution

  • 00192896109759 ()

  • Length: 4.5 Inch


  • Tenotome

Laryngoscopy Forceps - 00192896107700

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Oval Straight Quantum
SONTEC INSTRUMENTS, INC.
1301-234Q
In Commercial Distribution

  • 00192896107700 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107298

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Straight Quantum
SONTEC INSTRUMENTS, INC.
1301-222Q
In Commercial Distribution

  • 00192896107298 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

MAYO-HEGAR NEEDLE HOLDER - 00192896085749

MAYO-HEGAR NEEDLE HOLDER WITH STREAMLINED BOX LOCK TUNGSTEN CARBIDE SERRATED TIP QUANTUM
SONTEC INSTRUMENTS, INC.
2300-718Q
In Commercial Distribution

  • 00192896085749 ()

  • Length: 7 Inch
2300-718Q

  • Suturing needle holder, reusable

OLSEN HEGAR NEEDLE HOLDER - 00192896081130

OLSEN HEGAR NEEDLE HOLDER TUNGSTEN CARBIDE SERRATED TIP HEAVY 7.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-110HQ
In Commercial Distribution

  • 00192896081130 ()

  • Length: 7.5 Inch
1100-110HQ

  • Suturing needle holder, reusable

Orfit Industries - 05420028722756

Loxon Set for HP Head & Neck Base Plates for Quantum Couch - MRI Compatible
Orfit Industries NV
33218
In Commercial Distribution

  • 05420028722756 ()


  • DNA-based tissue typing IVD, reagent

QUANTUM™ CT Overlay - 10841962109038

QUANTUM CT Overlay for Somatom Plus 4,Volume Ct For 244cm long cradle
Qfix
RT-4550SS1
In Commercial Distribution

  • 10841962109038 ()

  • Length: 244 Centimeter
RT-4550SS1

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962108901

QUANTUM CT Overlay for GE Lightspeed RT CT For 207 cm long cradle
Qfix
RT-4550GER
In Commercial Distribution

  • 10841962108901 ()

  • Length: 207 Centimeter
RT-4550GER

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962108895

QUANTUM CT Overlay for GE Lightspeed + HiSpeed CT For 231 cm long cradle
Qfix
RT-4550GEL
In Commercial Distribution

  • 10841962108895 ()

  • Length: 231 Centimeter
RT-4550GEL

  • Indexed-immobilization patient positioning system

QUANTUM™ CT Overlay - 10841962108871

QUANTUM CT Overlay for GE Lightspeed VCT CT for 262 cm long cradle
Qfix
RT-4550GEC
In Commercial Distribution

  • 10841962108871 ()

  • Length: 262 Centimeter
RT-4550GEC

  • Indexed-immobilization patient positioning system

FREEMAN KAYE FACE LIFT SCISSORS - 00192896094833

FREEMAN KAY FACE LIFT SCISSORS MINIATURE STRAIGHT SPATULATED TIP POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-075Q
In Commercial Distribution

  • 00192896094833 ()

  • Length: 5 Inch
1200-075Q

  • Nasal scissors

WIRE PIN CUTTER - 00192896093904

WIRE/PIN CUTTER DOUBLE ACTION TUNGSTEN CARBIDE ANGLED TO SIDE 7.25 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-529Q
In Commercial Distribution

  • 00192896093904 ()

  • Length: 7.25 Inch
1100-529Q

  • Orthopaedic implantable-device cutter

LARGE PLATE/WIRE CUTTER - 00192896082588

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

  • 00192896082588 ()

  • Length: 9.5 Inch
1103-104Q

  • Orthopaedic implantable-device cutter

Stefan Mini Bone Holding Forceps - 00192896121577

Stefan Mini Bone Holding Forceps With Speed Lock Serrated Jaw Curved Delicate Quantum
SONTEC INSTRUMENTS, INC.
1103-003DQ
In Commercial Distribution

  • 00192896121577 ()

  • Length: 4 Inch
1103-003DQ

  • Bone holding forceps

Stefan Miniature Bone Holding Forceps - 00192896121157

Stefan Miniature Bone Holding Forceps Serrated Jaws With Long Ratchet Curved Tip Quantum
SONTEC INSTRUMENTS, INC.
1103-004Q
In Commercial Distribution

  • 00192896121157 ()

  • Length: 4 Inch
1103-004Q

  • Bone holding forceps

Classic Barraquer Needle Holder - 00192896120778

Classic Barraquer Needle Holder Medium Without Lock Delicate Curved Jaw Round Handle Quantum
SONTEC INSTRUMENTS, INC.
15-3812Q
In Commercial Distribution

  • 00192896120778 ()

  • Length: 5.25 Inch
15-3812Q

  • Suturing needle holder, reusable

Micro Surgery Needle Holder - 00192896117426

Micro Surgery Needle Holder Without Lock Curved Tungsten Carbide Tip Round Handle Quantum
SONTEC INSTRUMENTS, INC.
400-252Q
In Commercial Distribution

  • 00192896117426 ()

  • Length: 6 Inch
400-252Q

  • Suturing needle holder, reusable

Micro Surgery Needle Holder - 00192896117419

Micro Surgery Needle Holder Without Lock Straight Tungsten Carbide Tip Round Handle Quantum
SONTEC INSTRUMENTS, INC.
400-250Q
In Commercial Distribution

  • 00192896117419 ()

  • Length: 6 Inch
400-250Q

  • Suturing needle holder, reusable

Micro Bayonet Needle Holder - 00192896110168

Micro Bayonet Needle Holder Round Handle Tungsten Carbide Serrated Straight With Lock Quantum
SONTEC INSTRUMENTS, INC.
400-228Q
In Commercial Distribution

  • 00192896110168 ()

  • Length: 8.25 Inch


  • Suturing needle holder, reusable

Laryngoscopy Forceps - 00192896108806

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Oval Curved Right Quantum
SONTEC INSTRUMENTS, INC.
1301-238Q
In Commercial Distribution

  • 00192896108806 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107724

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Oval Curved Left Quantum
SONTEC INSTRUMENTS, INC.
1301-240Q
In Commercial Distribution

  • 00192896107724 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107717

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Oval Angled Up Quantum
SONTEC INSTRUMENTS, INC.
1301-236Q
In Commercial Distribution

  • 00192896107717 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107366

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 Millimeters Cup Curved Left Quantum
SONTEC INSTRUMENTS, INC.
1301-278Q
In Commercial Distribution

  • 00192896107366 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107342

Laryngoscopy Forceps Conical Tube 2 Millimeters Shaft 2.5 Millimeters Cup Curved Right Quantum
SONTEC INSTRUMENTS, INC.
1301-276Q
In Commercial Distribution

  • 00192896107342 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107328

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Curved Right Quantum
SONTEC INSTRUMENTS, INC.
1301-226Q
In Commercial Distribution

  • 00192896107328 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107311

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Curved Left Quantum
SONTEC INSTRUMENTS, INC.
1301-228Q
In Commercial Distribution

  • 00192896107311 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Laryngoscopy Forceps - 00192896107304

Laryngoscopy Forceps Conical Tube 1 Millimeter Shaft 1 Millimeter Cup Angled Up Quantum
SONTEC INSTRUMENTS, INC.
1301-224Q
In Commercial Distribution

  • 00192896107304 ()

  • Length: 9 Inch


  • Flexible endoscopic biopsy forceps, reusable

Adson Tissue Forceps - 00192896107007

ADSON TISSUE FORCEPS SERRATED HANDLE 1.3 MILLIMETER TIP 1 X 2 TEETH QUANTUM
SONTEC INSTRUMENTS, INC.
136-666Q
In Commercial Distribution

  • 00192896107007 ()

  • Length: 4.75 Inch


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

QUANTUM™ CT Overlay - 10841962111291

GE Gen2 QUANTUM CT Overlay for GE GT 1700 and GE NG2000V CT Scanners
Qfix
RT-4550GER2
In Commercial Distribution

  • 10841962111291 ()

  • Length: 207 Centimeter
RT-4550GER2

  • Indexed-immobilization patient positioning system
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