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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Surgical-Osteotomy
SATELEC
TKW3 II TIP N STER
In Commercial Distribution

  • 03609820876436 ()
F87643

  • Hard/soft-tissue ultrasonic surgical system
Surgical-Osteotomy
SATELEC
RHS3R M+ N STER TIP
In Commercial Distribution

  • 03609820876788 ()
F87678

  • Hard/soft-tissue ultrasonic surgical system
XDR CLARITY - Size-2 Digital Intraoral Sensor
CYBER MEDICAL IMAGING, INC.
XDR4P20SZ2
In Commercial Distribution

  • D787XDR4P20ADSZ20 ()

  • Length: 42.3 Millimeter
  • Width: 30.5 Millimeter
  • Height: 5.4 Millimeter


  • Dental digital imaging sensor, intraoral
Dental digital intraoral sensor, size 1
CYBER MEDICAL IMAGING, INC.
Anatomic Sensor, Size 1
In Commercial Distribution

  • D787215AC25B130A0 ()

  • Height: 5.40 Millimeter
  • Width: 24.35 Millimeter
  • Length: 36.73 Millimeter
215AC25B130A

  • Dental digital imaging sensor, intraoral
Dental digital intraoral sensor, size 2
CYBER MEDICAL IMAGING, INC.
Anatomic Sensor, Size 2
In Commercial Distribution

  • D787213AC25B11 ()

  • Height: 6.60 Millimeter
  • Length: 42.80 Millimeter
  • Width: 30.49 Millimeter
213AC25B1

  • Dental digital imaging sensor, intraoral
Dental digital intraoral sensor, size 1
CYBER MEDICAL IMAGING, INC.
Anatomic Sensor, Size 1
In Commercial Distribution

  • D787215AC25B11 ()

  • Length: 36.73 Millimeter
  • Width: 24.35 Millimeter
  • Height: 5.40 Millimeter
215AC25B1

  • Dental digital imaging sensor, intraoral
Dental digital intraoral sensor, size 2
CYBER MEDICAL IMAGING, INC.
Anatomic Sensor, Size 2
In Commercial Distribution

  • D787213AC25B130A0 ()

  • Width: 30.49 Millimeter
  • Length: 42.80 Millimeter
  • Height: 6.60 Millimeter
213AC25B130A

  • Dental digital imaging sensor, intraoral
SURTRON device model 400HP is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 400HP is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 400W and frequency of 425kHz.
LED SPA
400HP
In Commercial Distribution

  • 08033638321911 ()
10400.902/US

  • Electrosurgical system
SURTRON device model 160HF is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 160HF is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 150W and frequency of 4MHz.
LED SPA
160HF
In Commercial Distribution

  • 08033638321164 ()
10300.201/US

  • Electrosurgical system
SURTRON device model 200 is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 200 is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 200W and frequency of 600kHz.
LED SPA
200
In Commercial Distribution

  • 08033638321140 ()
10100.401/US

  • Electrosurgical system
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