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

  • 10884450619442 ()
  • 00884450619445 ()

  • French Size (F)-4F
  • Label Long Description-BERENSTEIN 1
  • Length-135 cm
  • Recommended Guide Wire-0.038" (0.97 mm)
PV413538BERN

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450619268 ()
  • 00884450619261 ()

  • French Size (F)-4F
  • Length-150 cm
  • Recommended Guide Wire-0.038" (0.97 mm)
  • Label Long Description-BERENSTEIN 1
PV415038BERN

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450618568 ()
  • 00884450618561 ()

  • Length-125 cm
  • Internal Diameter-0.046" (1.17 mm)
  • Recommended Guide Wire-0.038" (0.97 mm)
  • French Size (F)-5F
1628-D1

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450618018 ()
  • 00884450618011 ()

  • Internal Diameter-0.046" (1.17 mm)
  • Length-125 cm
  • Recommended Guide Wire-0.038" (0.97 mm)
  • French Size (F)-5F
1628-031

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450618001 ()
  • 00884450618004 ()

  • French Size-5F (1.7 mm)
  • Length-100 cm
  • Recommended Guide Wire-0.038" (0.97 mm)
  • Label Short Description-JL 3.0
1628-R1

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450617974 ()
  • 00884450617977 ()

  • Label Short Description-Spiral Angled Pig
  • Length-100 cm
  • Recommended Guide Wire-0.038" (0.97 mm)
  • French Size-6F (2.0 mm)
1625-37

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450617745 ()
  • 00884450617748 ()

  • French Size (F)-5F
  • Internal Diameter-0.046" (1.17 mm)
  • Length-125 cm
  • Recommended Guide Wire-0.038" (0.97 mm)
1628-111

  • Angiographic catheter, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450610630 ()
  • 00884450610633 ()
  • 20884450610637 ()

  • Size (Volume)-12 mL
STP601

  • General-purpose syringe, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450610616 ()
  • 00884450610619 ()
  • 20884450610613 ()

  • Size (Volume)-10 mL
ST801

  • General-purpose syringe, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450610593 ()
  • 00884450610596 ()
  • 20884450610590 ()

  • Size (Volume)-12 mL
ST601

  • General-purpose syringe, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450610579 ()
  • 00884450610572 ()
  • 20884450610576 ()

  • Size (Volume)-12 mL
ST600

  • General-purpose syringe, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450610555 ()
  • 00884450610558 ()
  • 20884450610552 ()

  • Size (Volume)-20 mL
ST320

  • General-purpose syringe, single-use
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
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450295608 ()
  • 00884450295601 ()

  • Catheter Length Tip-Cuff (cm)-31 cm
  • French Size (F)-15F
CENFT31K

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

  • 10884450295530 ()
  • 00884450295533 ()

  • French Size (F)-15F
  • Catheter Length Tip-Cuff (cm)-19 cm
CENFT19C

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

  • 10884450021344 ()
  • 00884450021347 ()
  • 20884450021341 ()
IN9802

  • Catheter/overtube balloon inflator, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450008772 ()
  • 00884450008775 ()

  • Introducer French Size (F)-5F
  • Needle Gauge (G)-21G
  • Introducer Length (cm)-10 cm (4")
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
MAK505-PED

  • Vascular dilator, single-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470708 ()
  • 00884450470701 ()

  • Infusion Segment Length (cm)-50 cm
  • French Size (F)-5F
  • Catheter Length (cm)-90 cm
FIS5-90-50-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470692 ()
  • 00884450470695 ()

  • Catheter Length (cm)-90 cm
  • Infusion Segment Length (cm)-5 cm
  • French Size (F)-5F
FIS5-90-5-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470661 ()
  • 00884450470664 ()

  • French Size (F)-5F
  • Infusion Segment Length (cm)-40 cm
  • Catheter Length (cm)-90 cm
FIS5-90-40-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470623 ()
  • 00884450470626 ()

  • Catheter Length (cm)-90 cm
  • Infusion Segment Length (cm)-30 cm
  • French Size (F)-5F
FIS5-90-30-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470609 ()
  • 00884450470602 ()

  • French Size (F)-5F
  • Infusion Segment Length (cm)-20 cm
  • Catheter Length (cm)-90 cm
FIS5-90-20-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470586 ()
  • 00884450470589 ()

  • French Size (F)-5F
  • Infusion Segment Length (cm)-10 cm
  • Catheter Length (cm)-90 cm
FIS5-90-10-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470562 ()
  • 00884450470565 ()

  • Infusion Segment Length (cm)-20 cm
  • French Size (F)-5F
  • Catheter Length (cm)-45 cm
FIS5-45-20-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470548 ()
  • 00884450470541 ()

  • Catheter Length (cm)-45 cm
  • Infusion Segment Length (cm)-10 cm
  • French Size (F)-5F
FIS5-45-10-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450470517 ()
  • 00884450470510 ()

  • Infusion Segment Length (cm)-50 cm
  • Catheter Length (cm)-135 cm
  • French Size (F)-5F
FIS5-135-50-V

  • Peripheral vascular intervention infusion catheter
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 00884450466384 ()

  • Sheath French Size-8.5F
  • Length (cm)-79.4 cm
  • Curve Angle-90°
FCL-160-08

  • Cardiac transseptal access set
No Description
MERIT MEDICAL SYSTEMS, INC.
A
In Commercial Distribution

  • 00884450449332 ()
PC10-N

  • Electromagnetic surgical navigation device tracking system
Light Weight Wheelchair
Bowhead Design Corporation
A
In Commercial Distribution

  • 00860013500900 ()


  • Push-rim manual wheelchair, non-bariatric
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
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
931
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008324 ()
991067S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
930
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008263 ()
991066S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
prolaio Convenience Kit - Model A
Prolaio, Inc.
A
In Commercial Distribution

  • 00850071330106 ()


  • Electrocardiography monitoring system receiver
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
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD
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 VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233118 ()


  • Radiology DICOM image processing application software
No Description
A1 SURGICAL SUPPLIES, LLC
A
In Commercial Distribution

  • 50860000082803 ()
  • 00860000082808 ()


  • Suction/irrigation tubing, single-use
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