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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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HYGENIC® Paper Points - E165H021141

HYGENIC® Absorbent Paper Points ISO 20
Coltène/Whaledent GmbH + Co. KG
H02114
In Commercial Distribution

  • E165H021140 ()
  • E165H021141 ()
H02114

  • Endodontic paper point

MicroMega Paper Points - E165600317462

MicroMega One RECI Paper Points 0.04 # 20
Coltène/Whaledent GmbH + Co. KG
60031746
In Commercial Distribution

  • E165600317460 ()
  • E165600317462 ()
60031746

  • Endodontic paper point

HyFlex™ Paper Points - E165600227421

HyFlex™ EDM Paper Points 0.05 # 20
Coltène/Whaledent GmbH + Co. KG
60022742
In Commercial Distribution

  • E165600227420 ()
  • E165600227421 ()
60022742

  • Endodontic paper point

HyFlex™ Paper Points - E165600226821

HyFlex™ CM Paper Points 0.06 # 20
Coltène/Whaledent GmbH + Co. KG
60022682
In Commercial Distribution

  • E165600226820 ()
  • E165600226821 ()
60022682

  • Endodontic paper point

HyFlex™ Paper Points - E165600226721

HyFlex™ CM Paper Points 0.04 # 20
Coltène/Whaledent GmbH + Co. KG
60022672
In Commercial Distribution

  • E165600226720 ()
  • E165600226721 ()
60022672

  • Endodontic paper point

HyFlex EDM - E165600222761

HyFlex EDM Preparation File 20/.05, 25mm
Coltène/Whaledent GmbH + Co. KG
60022276
In Commercial Distribution

  • E165600222760 ()
  • E165600222761 ()
60022276

  • Rotary/reciprocating endodontic file/rasp, reusable

HyFlex EDM - E165600222751

HyFlex EDM Preparation File 20/.05, 21mm
Coltène/Whaledent GmbH + Co. KG
60022275
In Commercial Distribution

  • E165600222750 ()
  • E165600222751 ()
60022275

  • Rotary/reciprocating endodontic file/rasp, reusable

ROEKO Paper Points - E1653445201

ROEKO Paper Points Top color ISO 20
Coltène/Whaledent GmbH + Co. KG
344520
In Commercial Distribution

  • E1653445200 ()
  • E1653445201 ()
344520

  • Endodontic paper point

Pisces-SA - B0621700S190

23x29x19, 20°, Sterile, Standalone ALIF Interbody, PISCES-SA
Osseus Fusion Systems, LLC
1700-S190S
In Commercial Distribution

  • B0621700S190 ()
1700-S190S

  • Metallic spinal interbody fusion cage

Pisces-SA - B0621700S170

23x29x17, 20°, Sterile, Standalone ALIF Interbody, PISCES-SA
Osseus Fusion Systems, LLC
1700-S170S
In Commercial Distribution

  • B0621700S170 ()
1700-S170S

  • Metallic spinal interbody fusion cage
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