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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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HOUSE BELLUCCI EAR SCISSORS - 00192896041387

HOUSE BELLUCCI EAR SCISSORS RIGHT CURVED BLADE QUANTUM
SONTEC INSTRUMENTS, INC.
469-087RQ
In Commercial Distribution

  • 00192896041387 ()

  • Length: 3.5 Inch
  • 4 Millimeter Blade
469-087RQ

  • Ear scissors, reusable

WIRE SUTURE SCISSORS - 00192896049673

WIRE SUTURE SCISSORS SERRATED ANGLED 5.0 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-308Q
In Commercial Distribution

  • 00192896049673 ()

  • Length: 5 Inch
1100-308Q

  • Suture scissors

STRABISMUS SCISSORS - 00192896047174

STRABISMUS SCISSORS STRAIGHT BLADE POWER CUT GOLD QUANTUM
SONTEC INSTRUMENTS, INC.
1200-020Q
In Commercial Distribution

  • 00192896047174 ()

  • Length: 4.5 Inch
1200-020Q

  • General-purpose surgical scissors, reusable

SPENCER SUTURE SCISSORS - 00192896047167

SPENCER SUTURE SCISSORS STRAIGHT DELICATE 4.50 INCHES QUANTUM
SONTEC INSTRUMENTS, INC.
1100-298DQ
In Commercial Distribution

  • 00192896047167 ()

  • Length: 4.5 Inch
1100-298DQ

  • Suture scissors

Natus - 00382830048453

Natus Quantum Amplifier system – 64 channels (phase II)
XLTEK
PK1258
In Commercial Distribution

  • 00382830048453 ()


  • Electroencephalograph

NAR - 00842209125159

KIT, QUANTUM ULTIMATE INTENSIVE RESUSCITATION CARRY (Q.U.I.C.K.) - BASIC
NORTH AMERICAN RESCUE, LLC
35-0026
In Commercial Distribution

  • 00842209125159 ()
35-0026

  • Conduction blood/fluid warmer
  • First aid kit, non-medicated, single-use

Mayo Dissecting Scissors - 00192896121928

Mayo Dissecting Scissors Classic Round Blades Straight Quantum
SONTEC INSTRUMENTS, INC.
1100-249Q
In Commercial Distribution

  • 00192896121928 ()

  • Length: 6 Inch
1100-249Q

  • General-purpose surgical scissors, reusable

Annalise Triage - G140ANNALISEENTP60

software versions 3.10+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
3.10.0+
In Commercial Distribution

  • G140ANNALISEENTP60 ()
AnnaliseENTP6

  • X-ray image interpretive software
  • Radiology DICOM image processing application software

ACPlus Respiratory Assessment - 00858703006344

Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional

Eureka - B2208430011

Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
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