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reSET® Mobile Application running on Android. 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
- 10851580008095 ()
- Mental health/function therapeutic software, screen-viewed
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution
- 00386270004642 ()
- Percutaneous interstitial fluid glucose monitoring system, electrochemical
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution
- 00606959042025 ()
1128265
- Self-care monitoring/reporting software
The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution
- 00817491023490 ()
FG-5902-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution
- 00817491022387 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution
- 00817491023612 ()
FG-5502-01-300
- Implantable glucose monitoring system
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution
- 00817491020826 ()
FG-5600-01-300
- Implantable glucose monitoring system
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution
- 08710103988977 ()
- Basic electric toothbrush
Wedding Band 5.5mm to 3.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5550
In Commercial Distribution
- 10889981033767 ()
- 5.5mm to 3.5mm
16-23-5550
- Bone-screw internal spinal fixation system connector
Slimline 3.5mm to 5.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5540
In Commercial Distribution
- 10889981033750 ()
- 3.5mm to 5.5mm
16-23-5540
- Bone-screw internal spinal fixation system connector