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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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NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - 00850044399062

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

Electro Lube - 00849771050414

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

Key Surgical Electro Lube - 00849771037873

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

DGH 2006 Corded Pachymeter Probe - 00857377006216

The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DGH 2006
In Commercial Distribution

  • 00857377006216 ()


  • Ophthalmic ultrasound imaging transducer

DET 2006 Detachable Pachymeter Probe - 00857377006247

The DET2006 is a small, removable probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DET 2006
In Commercial Distribution

  • 00857377006247 ()


  • Ophthalmic ultrasound imaging transducer

DGH 1006 Corded Pachymeter Probe - 00857377006209

The DGH1006 is a straight corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DGH 1006
In Commercial Distribution

  • 00857377006209 ()


  • Ophthalmic ultrasound imaging transducer

Soft K-Cot(R) - 00860275000361

The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
HISTOLOGICS, LLC
SFT-4200
In Commercial Distribution

  • 00860275000361 ()
  • 10860275000368 ()


  • Wound debridement tool

Swift® Applicator Tip - 05060652910039

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

Perfusion Clamp with Adaptor - 13700911900942

The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1025A
In Commercial Distribution

  • 23700911900949 ()
  • 13700911900942 ()
  • 53700911900940 ()
  • 33700911900946 ()


  • Kidney donor-organ preservation/transport perfusion set

Perfusion Clamp with Adaptor - 13700911900935

The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC715A
In Commercial Distribution

  • 23700911900932 ()
  • 13700911900935 ()
  • 53700911900933 ()
  • 33700911900939 ()


  • Kidney donor-organ preservation/transport perfusion set
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