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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 MRI Stretcher with Fowler positioning is non-magnetic, all aluminum, and designed for heavy-duty use.
Mirion Technologies (capintec), Inc.
240-110
In Commercial Distribution

  • 00879942070767 ()
240-110

  • MRI system table, non-powered
Tracheostomy Care Tray with Gloves, Sterile
Dynarex Corporation
14001
In Commercial Distribution

  • 00860008059567 ()
  • 00860008123244 ()


  • Tracheostomy tube neck holder, reusable
No Description
NINEPOINT MEDICAL, INC.
94301-MI
In Commercial Distribution

  • 00859591006249 ()
94301-MI

  • Endoscopic optical coherence tomography system
ZipCombo Centrifuge, hematocrit rotor, capacity 12-40mm tubes
LW SCIENTIFIC, INC.
ZCC-12HD-40T3
In Commercial Distribution

  • 00664816001745 ()


  • Microhaematocrit centrifuge IVD
No Description
Medicomp
MC-4425
In Commercial Distribution

  • 10858409005600 ()
  • 00858409005603 ()
MC-4425

  • Straight/elbow breathing circuit connector, single-use
No Description
Medicomp
MC-6605
In Commercial Distribution

  • 10858409005389 ()
  • 00858409005382 ()
MC-6605

  • Anaesthesia breathing circuit, single-use
The Molar Procedure Instrument with Accessories, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00025
In Commercial Distribution

  • 00858395006332 ()
  • 00858395006349 ()
GW-MOL-PI10

  • Dental delivery system instrument unit, electric
The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-001-00023
In Commercial Distribution

  • 00858395006325 ()
GW-MOL-PI01

  • Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00011
In Commercial Distribution

  • 00858395006318 ()
GW-APM-PI01

  • Dental delivery system instrument unit, electric
The Anterior/Premolar Procedure Instrument with Matrix, when used with the GentleWave Console, is intended to be used on the anterior or premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the procedure site.
SONENDO, INC.
FG-003-00010
In Commercial Distribution

  • 00858395006295 ()
  • 00858395006301 ()
GW-APM-PI10

  • Dental delivery system instrument unit, electric
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