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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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SURGITRON 4.0 DUAL RF/90 IEC 110V
Cynosure, LLC
IEC3A-S30-90/110
In Commercial Distribution

  • 00841494106690 ()
IEC3A-S30-90/110

  • Electrosurgical system
PELLEVE S5 GENERATOR, 110 USA
Cynosure, LLC
IEC5P-ST/110-USA
In Commercial Distribution

  • 00841494104207 ()
IEC5P-ST/110-USA

  • Electrosurgical system
PELLEVE S5 GENERATOR, 110 USA
Cynosure, LLC
IEC5P-ST/110-USA (MOD2)
In Commercial Distribution

  • 00841494104191 ()
IEC5P-ST/110-USA (MOD2)

  • Electrosurgical system
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-H/P
In Commercial Distribution

  • 08809709380466 ()


  • Electrosurgical system
XTHERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-Body
In Commercial Distribution

  • 08809709380459 ()


  • Electrosurgical system
10THERMA Handpiece
TENTECH Inc.
TMHP02
In Commercial Distribution

  • 08809709380350 ()


  • Electrosurgical system
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
TMSY02
In Commercial Distribution

  • 08809709380343 ()


  • 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 VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a nonconductive tip which is attached to a handle via a nonconductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a Temperature controlled radiofrequency generator (Aerin Console) via a flexible cable.
Aerin Medical Inc.
FG1787
In Commercial Distribution

  • 08886479300269 ()
CAT1785

  • Electrosurgical system
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