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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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HyFlex EDM - E165600222670

HyFlex EDM Shaping Set Simple 25/.12, 10/.05, 25/.~, 21mm
Coltène/Whaledent GmbH + Co. KG
60022267
In Commercial Distribution

  • E165600222670 ()
60022267

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196420

HyFlex™ EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm
Coltène/Whaledent GmbH + Co. KG
60019642
Not in Commercial Distribution

  • E165600196420 ()
60019642

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196410

HyFlex™ EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 25 mm
Coltène/Whaledent GmbH + Co. KG
60019641
Not in Commercial Distribution

  • E165600196410 ()
60019641

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196331

HyFlex™ EDM Finishing File 60/0.02 25 mm
Coltène/Whaledent GmbH + Co. KG
60019633
Not in Commercial Distribution

  • E165600196330 ()
  • E165600196331 ()
60019633

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196321

HyFlex™ EDM Finishing File 50/0.03 25 mm
Coltène/Whaledent GmbH + Co. KG
60019632
Not in Commercial Distribution

  • E165600196320 ()
  • E165600196321 ()
60019632

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196311

HyFlex™ EDM Finishing File 40/0.04 25 mm
Coltène/Whaledent GmbH + Co. KG
60019631
Not in Commercial Distribution

  • E165600196310 ()
  • E165600196311 ()
60019631

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196301

HyFlex™ EDM Orifice Opener 25/0.12 15 mm
Coltène/Whaledent GmbH + Co. KG
60019630
Not in Commercial Distribution

  • E165600196300 ()
  • E165600196301 ()
60019630

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196291

HyFlex™ EDM OneFile 25/~ 25 mm
Coltène/Whaledent GmbH + Co. KG
60019629
Not in Commercial Distribution

  • E165600196290 ()
  • E165600196291 ()
60019629

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex™ EDM - E165600196281

HyFlex™ EDM Glidepath File 10/0.05 25 mm
Coltène/Whaledent GmbH + Co. KG
60019628
Not in Commercial Distribution

  • E165600196280 ()
  • E165600196281 ()
60019628

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex EDM - E165600195991

HyFlex EDM Finishing File 60/.02, 25mm
Coltène/Whaledent GmbH + Co. KG
60019599
In Commercial Distribution

  • E165600195990 ()
  • E165600195991 ()
60019599

  • Rotary/reciprocating endodontic file/rasp, reusable
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