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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 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
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-003-00009
Not in Commercial Distribution

  • 00858395006288 ()
GW-APM-PI01

  • Dental delivery system instrument unit, electric
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-001-00020
In Commercial Distribution

  • 00858395006257 ()
  • 00858395006264 ()
GW-MOL-PI10

  • 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-003-00008
Not in Commercial Distribution

  • 00858395006240 ()
  • 00858395006233 ()
GW-APM-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-001-00022
In Commercial Distribution

  • 00858395006189 ()
GW-MOL-PI01

  • Dental delivery system instrument unit, electric
Tracheostomy Care Tray with Gloves, Sterile
Dynarex Corporation
14001
In Commercial Distribution

  • 00860008059567 ()
  • 00860008123244 ()


  • Tracheostomy tube neck holder, reusable
The Elos Torque Wrench (main body, head and Elos Driver) is made of lightweight titanium and stainless steel. The Elos Torque Wrench & Driver product design, finish and quality make the tool well suited for placement and adjustment of implants, abutments and screws during surgery and other clinical procedures. The Elos Torque Wrench & Driver is easy to prepare for cleaning, disinfection and sterilization. Exchangeable screwdrivers and the Elos Driver make the tool compatible to various implant systems. The driver is available for a variety of connections. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
C9866
In Commercial Distribution

  • 05712821006448 ()
  • 05712821006431 ()


  • Surgical torque wrench, reusable
Obstructive Sleep Apnea with Iterative Adjustment and Patient Monitoring
PROSOMNUS SLEEP TECHNOLOGIES
IA Monogram Monitor
In Commercial Distribution

  • 00863039000430 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.
TOOLS FOR SURGERY, LLC
HOP-AP
In Commercial Distribution

  • 00861838000316 ()

  • Length: 7 Millimeter
  • Outer Diameter: 10 Millimeter
HOP-AP

  • Skin stapler/staple, non-bioabsorbable
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