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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Sterile Surgical Lubricant, Packet
HR PHARMACEUTICALS INC.
281020557
In Commercial Distribution

  • 30851809002471 ()
  • 00851809002470 ()
  • 10851809002477 ()
  • 20851809002474 ()
  • 00281020557 ()

  • Weight: 31 Gram
281020557

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Sterile Surgical Lubricant, Metal Tube
HR PHARMACEUTICALS INC.
281020555
In Commercial Distribution

  • 30851809002464 ()
  • 20851809002467 ()
  • 10851809002460 ()
  • 00851809002463 ()
  • 00281020555 ()

  • Weight: 5 Gram
281020555

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Sterile Surgical Lubricant, Tube
HR PHARMACEUTICALS INC.
281020537
In Commercial Distribution

  • 20851809002450 ()
  • 10851809002453 ()
  • 00851809002456 ()
  • 00281020537 ()

  • Weight: 120.49 Gram
281020537

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Sterile Surgical Lubricant, Metal Tube
HR PHARMACEUTICALS INC.
281020536
In Commercial Distribution

  • 10851809002446 ()
  • 00851809002449 ()
  • 20851809002443 ()
  • 00281020536 ()

  • Weight: 120.49 Gram
281020536

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Sterile Surgical Lubricant, Tube
HR PHARMACEUTICALS INC.
281020512
In Commercial Distribution

  • 20851809002436 ()
  • 10851809002439 ()
  • 00851809002432 ()
  • 00281020512 ()

  • Weight: 56.7 Gram
281020512

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Sterile Surgical Lubricant, Metal Tube
HR PHARMACEUTICALS INC.
281020502
In Commercial Distribution

  • 20851809002429 ()
  • 10851809002422 ()
  • 00851809002425 ()
  • 00281020502 ()

  • Weight: 56.7 Gram
281020502

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Sterile Surgical Lubricant, Packet
HR PHARMACEUTICALS INC.
281020545
In Commercial Distribution

  • 20851809002412 ()
  • 10851809002415 ()
  • 00851809002418 ()
  • 00281020545 ()

  • Weight: 5 Gram
281020545

  • Multi-purpose surgical instrument lubricant
  • General-body orifice lubricant
Sterile Surgical Lubricant, Packet
HR PHARMACEUTICALS INC.
281020543
In Commercial Distribution

  • 20851809002405 ()
  • 10851809002408 ()
  • 00851809002401 ()
  • 00281020543 ()

  • Weight: 3 Gram
281020543

  • General-body orifice lubricant
  • Multi-purpose surgical instrument lubricant
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution

  • 00857335005121 ()
  • 57335-0005-12 ()
57335000512

  • Mental health/function therapeutic software, screen-viewed
FreeStyle Lite Blood Glucose Monitoring System
ABBOTT DIABETES CARE INC
71501
In Commercial Distribution

  • 30699073715013 ()
  • 00699073715012 ()
  • 99073-0715-01 ()
71501

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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