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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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IMAGE DIAGNOSTICS, INC. - 00850061871282

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS WITH RECORDER,ILEX DUO,120V,#A280-1569
IMAGE DIAGNOSTICS, INC.
ILEX DUO PLATINUM 32
In Commercial Distribution

  • 00850061871282 ()
A280-1569

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871275

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS,ILEX DUO,120V,#A280-1568
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT PREMIUM 32
In Commercial Distribution

  • 00850061871275 ()
A280-1568

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC. - 00850061871268

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 27IN. 4K MONITORS,ILEX DUO,120V,#A280-1567
IMAGE DIAGNOSTICS, INC.
ILEX DUO DIRECT CONNECT 27
In Commercial Distribution

  • 00850061871268 ()
A280-1567

  • Diagnostic x-ray digital imaging system workstation

TelePatch Cardiac Monitor - 00862887000371

TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM700
Not in Commercial Distribution

  • 00862887000371 ()


  • Electrocardiographic ambulatory recorder

Decipher Holter Monitor - 00862887000364

Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder

Cardiac Monitor - 00862887000357

Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM500
Not in Commercial Distribution

  • 00862887000357 ()


  • Electrocardiographic ambulatory recorder

CardioPAL SAVI - 00862887000340

CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM410
Not in Commercial Distribution

  • 00862887000340 ()


  • Electrocardiographic ambulatory recorder

Messenger - 00865190000304

Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software

Pulsaderm RED LED Skin Renewal - 00864918000312

Red LED Light for Wrinkles
PULSADERM LLC
PD5000R
In Commercial Distribution

  • 00864918000312 ()


  • Red/blue light phototherapy unit

A.C.E Red and Blue - 00864918000336

LED light for the treatment of acne
PULSADERM LLC
PD9500
In Commercial Distribution

  • 00864918000336 ()


  • Red/blue light phototherapy unit
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