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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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Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-A
Not in Commercial Distribution

  • 14560227799024 ()
  • 04560227799027 ()
  • 24560227799021 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS05US

  • Dental appliance fabrication material, thermoplastic
Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Pink.
SUN MEDICAL CO.,LTD.
MCL-011-A
Not in Commercial Distribution

  • 14560227799017 ()
  • 04560227799010 ()
  • 24560227799014 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS03US

  • Dental appliance fabrication material, thermoplastic
Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-A
Not in Commercial Distribution

  • 14560227799000 ()
  • 04560227799003 ()
  • 24560227799007 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS01US

  • Dental appliance fabrication material, thermoplastic
The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima Mini
In Commercial Distribution

  • 09351567000363 ()
O2VBM

  • Mandible-repositioning sleep-disordered breathing orthosis
The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima
In Commercial Distribution

  • 09351567000035 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
BresoHub is a component of BresoDX1. During a test, BresoHub is placed at the patient’s bedside to receive the data from BresoSensor and the pulse oximeter wirelessly, and it stores the data locally. BresoHub is powered by a provided power supply. This device is only sold USA.
BresoTec Inc
BTSM1US-DCU
In Commercial Distribution

  • 00990008600015 ()
BT0001-01

  • Home-use sleep apnoea recording system
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-H/P
In Commercial Distribution

  • 08809709380466 ()


  • Electrosurgical system
XTHERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-Body
In Commercial Distribution

  • 08809709380459 ()


  • Electrosurgical system
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
TMSY02
In Commercial Distribution

  • 08809709380343 ()


  • Electrosurgical system
A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. The Walker Holder is an accessory that mounts to a medical device to hold walkers.
Pride Mobility Products Corp
Walker Holder
In Commercial Distribution

  • 00606509800020 ()
N/A

  • Wheelchair crutch/walking stick holder
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