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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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Brasseler USA - 00887919823681

ES-SF NITI RF40 04 21MM 4P
Peter Brasseler Holdings, LLC
5027104U0
In Commercial Distribution

  • 00887919823681 ()


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

Brasseler USA - 00887919788867

XP-3D SHAPER RF30 21MM 6P
Peter Brasseler Holdings, LLC
5025846U1
In Commercial Distribution

  • 00887919788867 ()


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

Brasseler USA - 00887919788836

XP-3D SHAPER RF30 25MM 6P
Peter Brasseler Holdings, LLC
5025845U1
In Commercial Distribution

  • 00887919788836 ()


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

Brasseler USA - 00887919788805

XP-3D FINISHER R RF30 21MM 6P
Peter Brasseler Holdings, LLC
5025844U1
In Commercial Distribution

  • 00887919788805 ()


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

Brasseler USA - 00887919788775

XP-3D FINISHER R RF30 25MM 6P
Peter Brasseler Holdings, LLC
5025843U1
In Commercial Distribution

  • 00887919788775 ()


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

Brasseler USA - 00887919788744

XP-3D FINISHER RF25 21MM 6P
Peter Brasseler Holdings, LLC
5025842U1
In Commercial Distribution

  • 00887919788744 ()


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

Brasseler USA - 00887919788713

XP-3D FINISHER RF25 25MM 6P
Peter Brasseler Holdings, LLC
5024933U1
In Commercial Distribution

  • 00887919788713 ()


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

Brasseler USA - 00887919786450

K0338 XP-3D STARTER KIT 1P
Peter Brasseler Holdings, LLC
5026135U0
In Commercial Distribution

  • 00887919786450 ()


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

Brasseler USA - 00887919786399

K0336 XP-3D INTRO KIT 1P
Peter Brasseler Holdings, LLC
5026130U0
In Commercial Distribution

  • 00887919786399 ()


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

Brasseler USA - 00887919639442

SEQ ENDO COMPLETE SYSTEM IV 1P
Peter Brasseler Holdings, LLC
5019355U0
In Commercial Distribution

  • 00887919639442 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
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