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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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EDENTA - E312171216540151

Reamer with handle
EDENTA ETABLISSEMENT
171.21.654.015
In Commercial Distribution

  • E31217121654015101 ()
  • E312171216540151 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312171216540101

Reamer with handle
EDENTA ETABLISSEMENT
171.21.654.010
In Commercial Distribution

  • E31217121654010101 ()
  • E312171216540101 ()


  • Manual endodontic file/rasp, reusable

EDENTA - E312171216540081

Reamer with handle
EDENTA ETABLISSEMENT
171.21.654.008
In Commercial Distribution

  • E31217121654008101 ()
  • E312171216540081 ()


  • Manual endodontic file/rasp, reusable

NOBILIUM - M4820100NK0

WITALLOY WITH PLATINUM
CMP INDUSTRIES LLC
0100NK
In Commercial Distribution

  • M4820100NK0 ()


  • Dental casting non-noble alloy

Arthrex® - 00888867206946

FiberTak with SutureTape
ARTHREX, INC.
AR-3602
In Commercial Distribution

  • 00888867206946 ()
  • M150AR36021 ()
  • 10888867206943 ()
AR-3602

  • Tendon/ligament bone anchor, non-bioabsorbable

BioStamp® - B493BRCA02

Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder

Criticare - B4388100EPUS0

nGenuity with Printer
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100EP
In Commercial Distribution

  • B4388100EPUS0 ()


  • General-purpose multi-parameter bedside monitor

Criticare - B4388100E1US0

nGenuity with CO2
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100E1
In Commercial Distribution

  • B4388100E1US0 ()


  • General-purpose multi-parameter bedside monitor

Diamond Orthopedic, LLC - B551DMD311430

Handle with quick-coupling
DIAMOND ORTHOPEDIC, LLC
DMD-311-430
In Commercial Distribution

  • B551DMD311430 ()
DMD-311-430

  • Surgical screwdriver, reusable

Prima - D76845009K0

Base with Anatite
KEYSTONE DENTAL, INC.
45009K
Not in Commercial Distribution

  • D76845009K0 ()

  • Outer Diameter 10.0 - 10.0 mm
45009K

  • Dental implant suprastructure, permanent, preformed
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