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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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Fibered Dark. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Dark (684175) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019841660 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin
Light Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution

  • D0019800540 ()

  • Weight: 21 Gram


  • Dental appliance fabrication material, resin
Pink Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution

  • D0019800530 ()

  • Weight: 21 Gram


  • Dental appliance fabrication material, resin
NetCom Client is an application programming interface (API) that is intended to allow data transfer to/from the Pegasus software.
NEURALYNX, INC.
3.1.0
In Commercial Distribution

  • 00850011306673 ()
36-0301-0004

  • Electroencephalographic monitoring system
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
EL101
In Commercial Distribution

  • 60849771050416 ()
  • 10849771050411 ()
  • 00849771050414 ()
  • 00849771037873 ()
EL101

  • Electrosurgical electrode lubricant
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
EL-101
Not in Commercial Distribution

  • 10849771037870 ()
  • 00849771037873 ()

  • Total Volume: 4 Milliliter
EL101

  • Electrosurgical electrode lubricant
Swift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-ATO1
In Commercial Distribution

  • 05060652910039 ()
SWF-ATO1

  • Intraoperative gamma radiation detection system probe cover
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)
NORTH EAST SCIENTIFIC INC
R-410-154
In Commercial Distribution


  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Introducer Sheath Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral
The device FlexPointer is a navigation probe for image guided surgery. The device is component to the Cube4D Navigation system.
Fiagon GmbH
E012002
In Commercial Distribution

E012002

  • Multi-purpose stereotactic surgery system
White color handle, Oval, 1*7 wire,Diameteris 30 mm,outer diameter is 2.54mm , working length is 1600mm,working channel2.8mm
Micro-Tech (Nanjing) Co., Ltd.
NT-E-30/16-P
In Commercial Distribution

  • 16932503554524 ()
  • 06932503554527 ()
  • 26932503554521 ()
  • 56932503554522 ()
  • 66932503554529 ()

  • Outer Diameter: 2.54 Millimeter
  • Length: 160 Centimeter


  • Endoscope working-channel valve, single-use
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