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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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INFINIUM MEDICAL, INC.
R80
In Commercial Distribution

  • 00852087007577 ()


  • Electrosurgical system
The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Console via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure; directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.
NEURENT MEDICAL LIMITED
010-00089-000
In Commercial Distribution

  • 05391537940118 ()


  • Electrosurgical system
The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator via a flexible cable. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities. The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile cart for ease of use. The mobile cart includes a handle and basket. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.
NEURENT MEDICAL LIMITED
010-00043-000
Not in Commercial Distribution

  • 05391537940026 ()


  • Electrosurgical system
Electrosurgical device for soft tissue coagulation
BRERA MEDICAL INC
1
In Commercial Distribution

  • 00860008655806 ()


  • Electrosurgical system
The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Aerin Medical Inc.
MS1198
In Commercial Distribution

  • 08886479300214 ()
309-05

  • Electrosurgical system
The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch.
Aerin Medical Inc.
FG2045
In Commercial Distribution

  • 08886479300290 ()
CAT2046-01

  • Electrosurgical system
The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch
Aerin Medical Inc.
FG2045
In Commercial Distribution

  • 08886479300283 ()
CAT2046

  • Electrosurgical system
The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Aerin Medical Inc.
MS1223
In Commercial Distribution

  • 08886479300221 ()
CAT309-06

  • Electrosurgical system
The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Aerin Medical Inc.
MS1222
In Commercial Distribution

  • 08886479300207 ()
CAT309-04

  • Electrosurgical system
The foot switch is an accessory for use with the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Aerin Medical Inc.
CAT307
In Commercial Distribution

  • 08886479300139 ()
CAT307

  • Electrosurgical system
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