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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 NEATCAP® DREAMIES® T-M device is a single use medical device designed to provide hearing protection for infants during air or ground hospital transport, or magnetic resonance imaging (MRI). The Size XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® T-M devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XS
In Commercial Distribution

  • 00860008980700 ()
NEAT005-01

  • Infant acoustic earmuffs
No Description
Genabio Diagnostics Inc.
N/A
In Commercial Distribution

  • 00860008954817 ()
  • 86000895481700 ()
RA9-E02525

  • Multiple drugs of abuse IVD, control
No Description
Genabio Diagnostics Inc.
RA9-E02525
In Commercial Distribution

  • 00860008954800 ()
  • 10860008954807 ()
RA9-E02501

  • Multiple drugs of abuse IVD, control
Foldable Electric Wheelchair
Forcemech International LLC
NAVIGATOR XL
In Commercial Distribution

  • 00860008903693 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Foldable Electric Wheelchair
Forcemech International LLC
NAVIGATOR
In Commercial Distribution

  • 00860008903686 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Foldable Electric Wheelchair
Forcemech International LLC
VOYAGER R2
In Commercial Distribution

  • 00860008903624 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Foldable Electric Wheelchair
Forcemech International LLC
NAVIGATOR EVO
In Commercial Distribution

  • 00860008903617 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
Premium Foldable Electric Wheelchair
Forcemech International LLC
CARBON F1
In Commercial Distribution

  • 00860008903600 ()


  • Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible
The PureLift Pro Edition device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Edition unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
PRO EDITION
In Commercial Distribution

  • 00860008851048 ()

  • Height: 20.7 Centimeter
  • Width: 4.8 Centimeter
  • Outer Diameter: 4.5 Centimeter
PURELIFT PRO EDITION

  • Facial muscle cosmesis electrical stimulator
The PureLift Pro Plus device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
PRO PLUS
In Commercial Distribution

  • 00860008851031 ()

  • Height: 20.7 Centimeter
  • Width: 4.8 Centimeter
  • Outer Diameter: 4.5 Centimeter
PURELIFT PRO PLUS

  • Facial muscle cosmesis electrical stimulator
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