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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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The cordless elements IC obturation system combines a Downpack heat source with a Backfill extruder. The Downpack device provides fast heating of the heat plugger with precisely controlled temperature and timing, making it suitable for single-motion downpack obturation of the apical portion of the root canal. Utilizing single-use gutta-percha cartridges, the ergonomic Backfill device has a motorized extruder system for precise temperature and speed control for a 3-dimensional obturation of the root canal system.
META SYSTEMS CO., LTD.
Downpack
In Commercial Distribution

  • 08809455602171 ()
973-0631

  • Endodontic obturation system
The cordless elements IC obturation system combines a Downpack heat source with a Backfill extruder. The Downpack device provides fast heating of the heat plugger with precisely controlled temperature and timing, making it suitable for single-motion downpack obturation of the apical portion of the root canal. Utilizing single-use gutta-percha cartridges, the ergonomic Backfill device has a motorized extruder system for precise temperature and speed control for a 3-dimensional obturation of the root canal system.
META SYSTEMS CO., LTD.
Backfill
In Commercial Distribution

  • 08809455602164 ()
973-0630

  • Endodontic obturation system
No Description
Drägerwerk AG & Co. KGaA
MP01669
Not in Commercial Distribution

  • 04048675252528 ()
  • 04048675421061 ()


  • Anaesthesia face mask, single-use
  • Heat/moisture exchanger/microbial medical gas filter
  • Breathing circuit gas-flow sensor, reusable
  • Ventilator breathing circuit, single-use
  • PEEP valve, reusable
Monopolar post retainer for handles
ORANGE SURGICAL INSTRUMENTS, LLC
OSMPR
In Commercial Distribution

  • B354OSMPR0 ()
OSMPR

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Monopolar posts for handles
ORANGE SURGICAL INSTRUMENTS, LLC
OSMP
In Commercial Distribution

  • B354OSMP0 ()
OSMP

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Cardiac Tube Holder
ORANGE SURGICAL INSTRUMENTS, LLC
OSCVORTH
In Commercial Distribution

  • B354OSCVORTH0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
CM2, THERAPY HAMMER,LASER MODULE, AUTOSOUND, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010
Not in Commercial Distribution

  • 00850958007992 ()


  • Ultrasound coupling pad holder
  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
CM2, THERAPY HAMMER, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010
Not in Commercial Distribution

  • 00850958007985 ()


  • Ultrasound coupling pad holder
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
CM2, THERAPY HAMMER, LASER MODULE, 2X2 MS CLOTH, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010
Not in Commercial Distribution

  • 00850958007978 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
CM2, 5CM, LASER MODULE, 2X2 MS FOAM, LEAD CORDS, 5CM GELSHOTS & ADAPTOR
COMPASS HEALTH BRANDS CORP.
410-010
Not in Commercial Distribution

  • 00850958007961 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Physical therapy ultrasound system applicator, hand-held
  • Physical therapy ultrasound/neuromuscular stimulation system
  • Ultrasound coupling pad holder
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