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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 35, 06, 25mm
FKG Dentaire Sàrl
X7U350625S
Not in Commercial Distribution

  • 07640142444374 ()
  • 07640142443940 ()
X7U350625S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 45, 04, 29mm
FKG Dentaire Sàrl
X7U450429S
Not in Commercial Distribution

  • 07640142444251 ()
  • 07640142443803 ()
X7U450429S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 25, 04, 29mm
FKG Dentaire Sàrl
X7U250429S
Not in Commercial Distribution

  • 07640142444213 ()
  • 07640142443766 ()
X7U250429S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 20, 04, 29mm
FKG Dentaire Sàrl
X7U200429S
Not in Commercial Distribution

  • 07640142444206 ()
  • 07640142443759 ()
X7U200429S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 17, 04, 29mm
FKG Dentaire Sàrl
X7U170429S
Not in Commercial Distribution

  • 07640142444190 ()
  • 07640142443742 ()
X7U170429S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 45, 04, 25mm
FKG Dentaire Sàrl
X7U450425S
Not in Commercial Distribution

  • 07640142444183 ()
  • 07640142443728 ()
X7U450425S

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Ultra no 35, 04, 25mm
FKG Dentaire Sàrl
X7U350425S
Not in Commercial Distribution

  • 07640142444169 ()
  • 07640142443704 ()
X7U350425S

  • 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
ESX 40 .04 31MM 1PK
Peter Brasseler Holdings, LLC
5024928U0
In Commercial Distribution

  • 00887919742388 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
ESX 40 .04 25MM 1PK
Peter Brasseler Holdings, LLC
5024927U0
In Commercial Distribution

  • 00887919742357 ()


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