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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reSET-O® is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008101 ()
  • 96439-0020-01 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: - increase abstinence from a patient’s substances of abuse during treatment, and - increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008071 ()
  • 96439-0010-01 ()


  • Mental health/function therapeutic software, screen-viewed
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms. Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008255 ()
  • 96439-0030-01 ()


  • Mental health/function therapeutic software, screen-viewed
Zumi 4.5 Uterine Manipulator/Injector
Adler, Inc.
AI-611
In Commercial Distribution

  • 00810123207084 ()
  • 00810123207176 ()


  • Drug-delivery iontophoresis patch
Zami/Kronner 4.5 Uterine Manipulator
Adler, Inc.
AI-6003
In Commercial Distribution

  • 00810123207077 ()
  • 810123207183 ()


  • Liposuction system cannula, reusable
G5 Touchscreen Receiver
Dexcom, Inc.
STK-SR-001
Not in Commercial Distribution

  • 20386270000327 ()
  • 08627-0090-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT
IBSA FARMACEUTICI ITALIA SRL
GS3111
In Commercial Distribution

  • 08033638951057 ()
  • 89130-3111-1 ()

  • Total Volume: 2.25 Milliliter


  • Synovial fluid supplementation medium
FreeStyle Libre 14 day Sensor Kit NFRS
ABBOTT DIABETES CARE INC
71939
Not in Commercial Distribution

  • 30357599001026 ()
  • 00357599001025 ()
  • 57599-0001-02 ()
71939

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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