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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 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
The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVALFOAM1
In Commercial Distribution

  • 00849405035138 ()

  • Length: 20 Centimeter
  • Width: 15 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVAFOAM1
In Commercial Distribution

  • 00849405035121 ()

  • Length: 15 Centimeter
  • Width: 10 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVASFOAM1
In Commercial Distribution

  • 00849405035114 ()

  • Length: 7.5 Centimeter
  • Width: 10 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial
This item is the VUM-6 Tube for Dye Injection which is an integral part of the Valtchev Uterine Mobilizer, Model VUM-6. The tube has no stand alone functionality and is part of the VUM-6 device. This is a replacement part that can be ordered separately if needed.
Conkin Surgical Instruments Ltd
9A
In Commercial Distribution

  • 00627843701866 ()
9A

  • Uterine elevator
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