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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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Onyx-R® Files, Roane Tip, #20 25mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-15062
Not in Commercial Distribution

  • H834012150621 ()
  • 10381780482666 ()
  • 00381780482669 ()
012-15062

  • Manual endodontic file/rasp, single-use
Onyx-R® Files, Roane Tip, #20 21mm
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
012-15002
Not in Commercial Distribution

  • H834012150021 ()
  • 10381780482543 ()
  • 00381780482546 ()
012-15002

  • Manual endodontic file/rasp, single-use
Edge X7 Utopia no 20, 06, 29mm
FKG Dentaire Sàrl
X7U200629SE
In Commercial Distribution

  • 07640142444411 ()
  • 07640142445234 ()
X7U200629SE

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Utopia no 20, 06, 25mm
FKG Dentaire Sàrl
X7U200625SE
In Commercial Distribution

  • 07640142444343 ()
  • 07640142445166 ()
X7U200625SE

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Utopia no 20, 06, 21mm
FKG Dentaire Sàrl
X7U200621SE
In Commercial Distribution

  • 07640142444275 ()
  • 07640142445098 ()
X7U200621SE

  • Rotary/reciprocating endodontic file/rasp, single-use
Edge X7 Utopia no 20, 04, 21mm
FKG Dentaire Sàrl
X7U200421SE
In Commercial Distribution

  • 07640142444060 ()
  • 07640142444886 ()
X7U200421SE

  • 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
K-Files 154, 31 mm, # 20, handle SMG
FKG Dentaire Sàrl
01.154.31.020.CG
In Commercial Distribution

  • 07640142415954 ()
01.154.31.020.CG

  • Manual endodontic file/rasp, reusable
B-K Micro Cervical Curette, backward angled, 2-0
BOSS INSTRUMENTS, LTD., INC.
70-7621
In Commercial Distribution

  • 00888515163423 ()
70-7621

  • Neurosurgical curette, reusable
B-K Micro Cervical Curette, Backward Straight, 2-0
BOSS INSTRUMENTS, LTD., INC.
70-7616
In Commercial Distribution

  • 00888515163379 ()
70-7616

  • Neurosurgical curette, reusable
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