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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 medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion. • A set of trackers intended to be placed on the patient’s head and in patient’s mouth. • A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in right-handed configurations.
MODJAW
TIM US
In Commercial Distribution

  • 03770022347250 ()


  • Jaw physiology evaluation system
28A-1 Roll In Cot, Blue
FERNO-WASHINGTON, INC.
0163282
Not in Commercial Distribution

  • 00190790001278 ()


  • Ambulance stretcher, manual
28A-1 Roll In Cot, Red
FERNO-WASHINGTON, INC.
0163281
In Commercial Distribution

  • 00190790001261 ()


  • Ambulance stretcher, manual
28A Roll In Cot, Aero
FERNO-WASHINGTON, INC.
0063099
In Commercial Distribution

  • 00190790001087 ()


  • Ambulance stretcher, manual
In Bed Arm Elevator 16" X 13.25" X 12"
GENEVA HEALTHCARE, LLC
2000
In Commercial Distribution

  • 00810044960983 ()
  • 10810044960980 ()
2000

  • Freestanding patient positioner, single-use
This package contains 50 RES003-1 Units.
SUNSET HEALTHCARE SOLUTIONS, INC.
RES003-1
In Commercial Distribution

  • 00848530082284 ()
  • 10848530082281 ()
RES003-1

  • CPAP/BPAP unit ambient air filter, reusable
The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. P/N: BBR-B-I-N
BIOINTELLISENSE, INC.
BIOST0604F v2.1
In Commercial Distribution

  • 00850005949282 ()
  • 10850005949289 ()
  • 20850005949286 ()
  • 30850005949283 ()


  • Wearable multiple physiological parameter recorder, reusable
Oxygen In Use Signs (50/pack)
SUNSET HEALTHCARE SOLUTIONS, INC.
RES003
In Commercial Distribution

  • 00848530060077 ()
  • 10848530060074 ()

  • 800cc
RES003

  • Surgical suction system collection container, single-use
No Description
KEELER LIMITED
2903-P-7001
In Commercial Distribution

  • 05055272715140 ()


  • Skin transilluminator, battery-powered
LED PLUG IN TRANSFORMER
SONTEC INSTRUMENTS, INC.
X-095.16.310
In Commercial Distribution

  • 00192896071766 ()
X-095.16.310

  • General physical examination set
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