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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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10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS10000
In Commercial Distribution

  • 10858629005039 ()
  • 00858629005032 ()
SMS10000

  • Sharps container
3.3 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
WCM WASTE & COMPLIANCE MANAGEMENT INC
SMS2400
In Commercial Distribution

  • 10858629005015 ()
  • 00858629005018 ()
SMS2400

  • Sharps container
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.The state of the treatment can be confirmed by the radiopacity of iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.
Meta Biomed Co., Ltd.
9482
In Commercial Distribution

  • 08806387894827 ()


  • Endodontic temporary cement
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.The state of the treatment can be confirmed by the radiopacity of iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.
Meta Biomed Co., Ltd.
9480
In Commercial Distribution

  • 08806387894803 ()


  • Endodontic temporary cement
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.The state of the treatment can be confirmed by the radiopacity of iodoform contained.Metapex Plus is used for patients of all ages requiring root canal treatment.
Meta Biomed Co., Ltd.
9479
In Commercial Distribution

  • 08806387894797 ()


  • Endodontic temporary cement
Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.
IMPEDIMED LIMITED
V 5.0.0
In Commercial Distribution

  • B277SOZOAPP0 ()


  • Bioelectrical body composition analyser
Multipurpose software application- impedance analysis software that supports the measurement of extracellular fluid volume differences between the limbs and in the whole body, to track changes in the fluid state overtime; impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio, that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.
IMPEDIMED LIMITED
V 5.0.0
In Commercial Distribution

  • B277SFT0250 ()
SFT-025

  • Bioelectrical body composition analyser
The Beacon transponder is a wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The resonance signal is used to measure the location of the transponders by the Calypso System. The Surface Beacon transponder is comprised of two Beacon transponders. The Surface Beacon transponder in its final packaged state is known as the Beacon Care Package - Surface.
VARIAN MEDICAL SYSTEMS, INC.
ASM0485-000
In Commercial Distribution

  • 00850011006016 ()
ASM0485-000

  • Real-time position management respiratory gating system, optical
The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, the Nova HD+ is easy to operate and incorporates many features to improve or facilitate muscle performance. The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Aura Wellness, LLC
Nova HD+ Starter Kit
In Commercial Distribution

  • 00850026680188 ()
APN-00053

  • Deep-tissue electromagnetic stimulation system, home-use
The Nova HD+ Pulsed Electromagnetic Therapy device from Aura Wellness has been designed specifically for the Human Healthcare Market. Using state of the art design concepts and Human Factor Principles, the Nova HD+ is easy to operate and incorporates many features to improve or facilitate muscle performance. The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Aura Wellness, LLC
Nova HD+
In Commercial Distribution

  • 00850026680072 ()
APN-00067

  • Deep-tissue electromagnetic stimulation system, home-use
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