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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 Finishing File 50/.03, 25mm
Coltène/Whaledent GmbH + Co. KG
60019598
In Commercial Distribution

  • E165600195980 ()
  • E165600195981 ()
60019598

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM Finishing File 40/.04, 25mm
Coltène/Whaledent GmbH + Co. KG
60019597
In Commercial Distribution

  • E165600195970 ()
  • E165600195971 ()
60019597

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM Orifice Opener 25/.12, 15mm
Coltène/Whaledent GmbH + Co. KG
60019596
In Commercial Distribution

  • E165600195960 ()
  • E165600195961 ()
60019596

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM OneFile 25/.~, 25mm
Coltène/Whaledent GmbH + Co. KG
60019595
In Commercial Distribution

  • E165600195950 ()
  • E165600195951 ()
60019595

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM Glidepath File 10/.05, 25mm
Coltène/Whaledent GmbH + Co. KG
60019594
In Commercial Distribution

  • E165600195940 ()
  • E165600195941 ()
60019594

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM Finishing Set 40/.04, 50/.03, 60/.02, 25mm
Coltène/Whaledent GmbH + Co. KG
60019364
In Commercial Distribution

  • E165600193640 ()
60019364

  • Rotary/reciprocating endodontic file/rasp, reusable
HyFlex EDM Shaping Set Simple 25/.12, 10/.05, 25/.~, 25mm
Coltène/Whaledent GmbH + Co. KG
60019363
In Commercial Distribution

  • E165600193630 ()
60019363

  • Rotary/reciprocating endodontic file/rasp, reusable
JMU NITI ROTARY FILES, VT-B UPG FILES, 01/09(19mm), 20/04, 25/04, 30/04, 35/04, 25/06(31mm), Sterilized Packing, 6pcs/Pk, #PRO-FLEXI FILES (BLUE)
JMU DENTAL, INC
22801045
In Commercial Distribution

  • 00840456213506 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
JMU NITI ROTARY FILES, VT-B UPG FILES, 25/06(31mm), Sterilized Packing, 6pcs/Pk, #PRO-FLEXI FILES (BLUE)
JMU DENTAL, INC
22801044
In Commercial Distribution

  • 00840456213490 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
JMU NITI ROTARY FILES, VT-B UPG FILES, 30/04(31mm), Sterilized Packing, 6pcs/Pk, #PRO-FLEXI FILES (BLUE)
JMU DENTAL, INC
22801043
In Commercial Distribution

  • 00840456213483 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
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