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 Class Implantable

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PAD, TABLE, 1.25" x 26" x 78"
DOMICO MED-DEVICE, LLC
172-20
In Commercial Distribution

  • 00810050240888 ()

  • Height: 1.25 Inch
  • Width: 26 Inch
  • Length: 78 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1" x 24" x 72"
DOMICO MED-DEVICE, LLC
171-20
In Commercial Distribution

  • 00810050240871 ()

  • Height: 1 Inch
  • Width: 24 Inch
  • Length: 72 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.5" x 27" x 78"
DOMICO MED-DEVICE, LLC
173-20
In Commercial Distribution

  • 00810050244015 ()

  • Height: 1.5 Inch
  • Width: 27 Inch
  • Length: 78 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1" x 24" x 60"
DOMICO MED-DEVICE, LLC
175-185
Not in Commercial Distribution

  • 00810050243766 ()

  • Height: 1 Inch
  • Width: 24 Inch
  • Length: 60 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1" x 21" x 42"
DOMICO MED-DEVICE, LLC
174-184
In Commercial Distribution

  • 00810050243759 ()

  • Height: 1 Inch
  • Width: 21 Inch
  • Length: 42 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNS
In Commercial Distribution

  • B660RMNS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution

  • B660RMNXS0 ()


  • Voice synthesizer/digitizer
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