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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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This is a medical device.This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.005.9311
In Commercial Distribution

  • EKAV100593110 ()
2008

  • Ultrasonic dental scaling/debridement system
SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
Lineus Medical
A
In Commercial Distribution

  • 10860635000311 ()
2855-01-0001

  • Luer/Luer breakaway connector
NEUWAVE Arm 2 Dovetail Rail
NEUWAVE MEDICAL, INC.
ARM2
In Commercial Distribution

  • 00853719006982 ()
ARM2

  • Microwave ablation system generator
NEUWAVE Arm 1 OR Table Rail
NEUWAVE MEDICAL, INC.
ARM1
In Commercial Distribution

  • 00853719006975 ()
ARM1

  • Microwave ablation system generator
Refurb NW Ablation System, US
NEUWAVE MEDICAL, INC.
NWC1US1R
Not in Commercial Distribution

  • 00853719006555 ()
  • 00853719006968 ()
NWC1US1R

  • Microwave ablation system generator
NEUWAVE Ablation System with Ablation Confirmation, US
NEUWAVE MEDICAL, INC.
NWA1US1N
Not in Commercial Distribution

  • 00853719006999 ()
  • 00853719006951 ()
NWA1US1N

  • Microwave ablation system generator
NW Ablation System, US
NEUWAVE MEDICAL, INC.
NWC1US1N
In Commercial Distribution

  • 00853719006753 ()
NWC1US1N

  • Microwave ablation system generator
Surgical Probe Kit
NEUWAVE MEDICAL, INC.
PRSURGKT
Not in Commercial Distribution

  • 00853719006531 ()
PRSURGKT

  • Microwave ablation system probe, non-powered
Surgical PDM Mount Kit
NEUWAVE MEDICAL, INC.
PD2MSURG
In Commercial Distribution

  • 00853719006524 ()
PD2MSURG

  • Microwave ablation system generator
Footswitch Locking USB
NEUWAVE MEDICAL, INC.
FSWITCH2
In Commercial Distribution

  • 00853719006517 ()
FSWITCH2

  • Microwave ablation system generator
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