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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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Edge X7 Ultra no 45, 04, 21mm
FKG Dentaire Sàrl
X7U450421S
Not in Commercial Distribution

  • 07640142444114 ()
  • 07640142443643 ()
X7U450421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 40, 04, 21mm
FKG Dentaire Sàrl
X7U400421S
Not in Commercial Distribution

  • 07640142444107 ()
  • 07640142443636 ()
X7U400421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 35, 04, 21mm
FKG Dentaire Sàrl
X7U350421S
Not in Commercial Distribution

  • 07640142444091 ()
  • 07640142443629 ()
X7U350421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 30, 04, 21mm
FKG Dentaire Sàrl
X7U300421S
Not in Commercial Distribution

  • 07640142444084 ()
  • 07640142443612 ()
X7U300421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 25, 04, 21mm
FKG Dentaire Sàrl
X7U250421S
Not in Commercial Distribution

  • 07640142444077 ()
  • 07640142443605 ()
X7U250421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 20, 04, 21mm
FKG Dentaire Sàrl
X7U200421S
Not in Commercial Distribution

  • 07640142444060 ()
  • 07640142443599 ()
X7U200421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 17, 04, 21mm
FKG Dentaire Sàrl
X7U170421S
Not in Commercial Distribution

  • 07640142444053 ()
  • 07640142443582 ()
X7U170421S

  • Rotary/reciprocating endodontic file/rasp, single-use
Sterile Endodontic Rotary File
US ENDODONTICS, LLC
EOBURG1431SU
In Commercial Distribution

  • 10818365029409 ()
  • 00818365029402 ()
EOBURG1431SU

  • Rotary/reciprocating endodontic file/rasp, single-use
Sterile Endodontic Rotary File
US ENDODONTICS, LLC
EOBURG1425SU
In Commercial Distribution

  • 10818365029393 ()
  • 00818365029396 ()
EOBURG1425SU

  • Rotary/reciprocating endodontic file/rasp, single-use
Sterile Endodontic Rotary File
US ENDODONTICS, LLC
EOBURG1421SU
In Commercial Distribution

  • 10818365029386 ()
  • 00818365029389 ()
EOBURG1421SU

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