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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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No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450809617 ()

  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
  • Introducer Length (cm)-10 cm (4")
  • Introducer French Size (F)-4F
  • Needle Gauge (G)-21G
ACE401PTE

  • Laparoscopic access cannula, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450809584 ()
  • 00884450809587 ()

  • Needle Gauge (G)-21G
  • Introducer Length (cm)-10 cm (4")
  • Introducer French Size (F)-4F
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
ACE401PTS

  • Laparoscopic access cannula, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450808122 ()
H787768022019S1

  • Lung biopsy procedure kit
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450804275 ()
  • 00884450804278 ()

  • French Size (F)-14.5F
H787103036035

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450804179 ()

  • French Size (F)-14.5F
H787103035095

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450804162 ()

  • French Size (F)-14.5F
H787103035085

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450804148 ()

  • French Size (F)-14.5F
H787103035065

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450804131 ()

  • French Size (F)-14.5F
H787103035055

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450804124 ()

  • French Size (F)-14.5F
H787103035045

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450804117 ()

  • French Size (F)-14.5F
H787103035035

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450803684 ()

  • French Size (F)-14.5F
H787103035025

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450803677 ()

  • French Size (F)-14.5F
H787103035015

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 20884450569379 ()
  • 10884450569372 ()
  • 00884450569375 ()

  • Tubing Length (in/cm)-60" (152 cm)
PM6160-R

  • Radiographic procedure tubing
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450564370 ()
HEROALLY

  • Arteriovenous shunt
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450544966 ()
  • 00884450544969 ()
  • 20884450544963 ()
ASP-4

  • Pleural/peritoneal drainage catheterization kit
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450544959 ()
  • 00884450544952 ()
ASP-10

  • Pleural/peritoneal drainage catheterization kit
pNeuton Ventilator, model A
AIRON CORPORATION
A
In Commercial Distribution

  • 00853678006009 ()

  • Depth: 7.3 Inch
  • Width: 10.0 Inch
  • Height: 5.0 Inch
  • Weight: 6.5 Pound
20052

  • Portable pneumatic ventilator
InnoVoyce VYLO Cart
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812180 ()
LC-00455

  • General/multiple surgical diode laser system
InnoVoyce VYLO Footswitch
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812111 ()
PRT-301009

  • General/multiple surgical diode laser system
InnoVoyce VYLO Eye Safety Filter Zeiss
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812104 ()
ASY-300144

  • General/multiple surgical diode laser system
Light Weight Wheelchair
Bowhead Design Corporation
A
In Commercial Distribution

  • 00860013500900 ()


  • Push-rim manual wheelchair, non-bariatric
The QT Scanner 2000 Model A is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator. The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
Qt Imaging, Inc.
A
In Commercial Distribution

  • 00852619008003 ()
100366

  • General-purpose ultrasound imaging system
InnoVoyce VYLO Eye Safety Filter Leica
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755999 ()
ASY-300143

  • General/multiple surgical laser system beam guide, reusable
InnoVoyce Laser Fiber .600 1 Pack
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755975 ()
  • 00860004755944 ()
ASY-300063-600

  • General/multiple surgical solid-state laser system
InnoVoyce Laser Fiber .400 1 Pack
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755968 ()
  • 00860004755937 ()
ASY-300063-400

  • General/multiple surgical solid-state laser system
InnoVoyce Laser Fiber .300 1 Pack
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755951 ()
  • 00860004755920 ()
ASY-300063-300

  • General/multiple surgical solid-state laser system
KTP Laser Fiber 600
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755913 ()
  • 10860004755903 ()

  • Outer Diameter: 600 Micrometer
KLF-001-600

  • General/multiple surgical laser system beam guide, single-use
KTP Laser Fiber 400
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755906 ()
  • 20860004755900 ()

  • Outer Diameter: 400 Micrometer
KLF-001-400

  • General/multiple surgical laser system beam guide, single-use
No Description
PARKER-HANNIFIN CORPORATION
A
In Commercial Distribution

  • 00860002624914 ()
  • 00860002624921 ()


  • Ventricular cerebrospinal fluid drainage catheterization kit
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233101 ()


  • Radiology DICOM image processing application software
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