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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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VascuTherm5 Therapy System
THERMOTEK, INC.
0P9PTVT500
In Commercial Distribution

  • B5850P9PTVT5000 ()
0P9PTVT500

  • Single-chamber venous compression system garment, single-use
  • Circulating-fluid localized thermal therapy system pack, single-use
  • Circulating-fluid localized thermal/compression therapy system wrap
  • Circulating-fluid localized thermal/compression therapy system control unit
VascuTherm4 Therapy System
THERMOTEK, INC.
0P9PTVT400
In Commercial Distribution

  • B5850P9PTVT4000 ()
0P9PTVt400

  • Single-chamber venous compression system garment, reusable
  • Circulating-fluid localized thermal therapy system pack, single-use
  • Circulating-fluid localized thermal/compression therapy system wrap
  • Circulating-fluid localized thermal/compression therapy system control unit
PT9 Therapy System
THERMOTEK, INC.
0P9PT09SYS
In Commercial Distribution

  • B5850P9PT09SYS0 ()
0P9PT09SYS

  • Single-chamber venous compression system garment, reusable
  • Circulating-fluid localized thermal therapy system pack, single-use
  • Circulating-fluid localized thermal/compression therapy system wrap
  • Circulating-fluid localized thermal/compression therapy system control unit
The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aesthetic applications – Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Forma-I and Forma Handpieces employs bi-polar Radiofrequency (RF) technology for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation; Lumecca IPL for treatment of superficial vascular and pigmented lesions; and Morpheus8 for electro-coagulation. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.
INMODE M.D LTD
AG609993A
In Commercial Distribution

  • 07290016633726 ()
AG609993A

  • Multi-modality skin surface treatment system
The InMode OP System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Light (IPL), and Radiofrequency (RF).
INMODE M.D LTD
AG605893A
In Commercial Distribution

  • 07290019863311 ()
AG605893A

  • Multi-modality skin surface treatment system
No Description
Drägerwerk AG & Co. KGaA
MP01656
In Commercial Distribution

  • 04048675251194 ()
  • 04048675421153 ()


  • Heat/moisture exchanger/microbial medical gas filter
  • Ventilator breathing circuit, single-use
  • Neonatal/adult intensive-care ventilator
  • Straight/elbow breathing circuit connector, single-use
No Description
Drägerwerk AG & Co. KGaA
MP01657
In Commercial Distribution

  • 04048675251309 ()
  • 04048675421146 ()


  • Heat/moisture exchanger/microbial medical gas filter
  • Ventilator breathing circuit, single-use
  • Neonatal/adult intensive-care ventilator
  • Straight/elbow breathing circuit connector, single-use
No Description
Drägerwerk AG & Co. KGaA
MP01673
In Commercial Distribution

  • 04048675252498 ()
  • 04048675421047 ()


  • Straight/elbow breathing circuit connector, single-use
  • Heat/moisture exchanger/microbial medical gas filter
  • Ventilator breathing circuit, single-use
  • Neonatal/adult intensive-care ventilator
No Description
Drägerwerk AG & Co. KGaA
MP01674
In Commercial Distribution

  • 04048675252481 ()
  • 04048675421030 ()


  • Straight/elbow breathing circuit connector, single-use
  • Heat/moisture exchanger/microbial medical gas filter
  • Ventilator breathing circuit, single-use
  • Neonatal/adult intensive-care ventilator
No Description
Drägerwerk AG & Co. KGaA
MP01676
In Commercial Distribution

  • 04048675252511 ()
  • 04048675421023 ()


  • Straight/elbow breathing circuit connector, single-use
  • Heat/moisture exchanger/microbial medical gas filter
  • Ventilator breathing circuit, single-use
  • Neonatal/adult intensive-care ventilator
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