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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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Tissue Contouring System, 115V
COLTENE/WHALEDENT INC
S8115
In Commercial Distribution

  • D661S81150 ()


  • Electrosurgical system generator
3 Sterilizable Electrode Sheaths
COLTENE/WHALEDENT INC
S7010A
In Commercial Distribution

  • D661S7010A0 ()


  • Electrosurgical system generator
Hand Piece Holder
COLTENE/WHALEDENT INC
S7001
In Commercial Distribution

  • D661S70010 ()


  • Electrosurgical system generator
Two 90º AP 1 1/2 Electrode Sheaths
COLTENE/WHALEDENT INC
S6018A
In Commercial Distribution

  • D661S6018A0 ()
  • D661500074710 ()


  • Electrosurgical system generator
Two 45º Diamond Loop Electrode Sheaths
COLTENE/WHALEDENT INC
S6017A
In Commercial Distribution

  • D661S6017A0 ()
  • D661500074680 ()


  • Electrosurgical system generator
Two Straight Long Loop Electrode Sheaths
COLTENE/WHALEDENT INC
S6016A
In Commercial Distribution

  • D661S6016A0 ()
  • D661500074690 ()


  • Electrosurgical system generator
Two 45º Long Loop Electrode Sheaths
COLTENE/WHALEDENT INC
S6015A
In Commercial Distribution

  • D661S6015A0 ()
  • D661500074700 ()


  • Electrosurgical system generator
Two Straight Round Loop Electrode Sheaths
COLTENE/WHALEDENT INC
S6014A
In Commercial Distribution

  • D661S6014A0 ()
  • D661500074720 ()


  • Electrosurgical system generator
Two 45º Tapered Knife Electrode Sheaths
COLTENE/WHALEDENT INC
S6013A
In Commercial Distribution

  • D661S6013A0 ()
  • D661500074740 ()


  • Electrosurgical system generator
Two 45º Straight Knife Electrode Sheaths
COLTENE/WHALEDENT INC
S6012A
In Commercial Distribution

  • D661S6012A0 ()
  • D661500074730 ()


  • Electrosurgical system generator
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