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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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reSET® - 10851580008040

reSET Web Dashboard is available using an internet browser. 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.
1.4
Not in Commercial Distribution

  • 10851580008040 ()


  • Mental health/function therapeutic software, screen-viewed

reSET® - 10851580008033

reSET Mobile Application runs 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.
1.5
Not in Commercial Distribution

  • 10851580008033 ()
N/A

  • Mental health/function therapeutic software, screen-viewed

reSET® - 10851580008026

reSET Mobile Application runs on iOS. 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.
1.5
Not in Commercial Distribution

  • 10851580008026 ()
N/A

  • Mental health/function therapeutic software, screen-viewed

reSET® - 10851580008019

"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.
1.4.6
Not in Commercial Distribution

  • 10851580008019 ()


  • Mental health/function therapeutic software, screen-viewed

Evaluator - 10850390007373

A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model.
BTE TECHNOLOGIES, INC.
Evaluator EV
Not in Commercial Distribution

  • 10850390007373 ()


  • Biomechanical function analysis system, force-testing, portable

EVJ - 10850390007366

A portable measurement system for quantifying musculoskeletal strength and range of motion.
BTE TECHNOLOGIES, INC.
Evaluator EVJ
In Commercial Distribution

  • 10850390007366 ()


  • Biomechanical function analysis system, force-testing, portable

Evaluator EV2 - 10850390007342

No Description
BTE TECHNOLOGIES, INC.
EV2
Not in Commercial Distribution

  • 10850390007342 ()


  • Biomechanical function analysis system, force-testing, portable

Evaluator - 10850390007335

A portable measurement system for quantifying musculoskeletal strength and range of motion.
BTE TECHNOLOGIES, INC.
Evaluator
In Commercial Distribution

  • 10850390007335 ()


  • Biomechanical function analysis system, force-testing, portable

REGO HUB,RAULAND R5,1FT-NC CABLE,6FT-PWR CABLE - 00840828186353

REGO HUB,RAULAND R5,1FT-NC CABLE,6FT-PWR CABLE
CURBELL MEDICAL PRODUCTS, INC.
HB01-90000001016
In Commercial Distribution

  • 00840828186353 ()
27802

  • Nurse call system

rebless planar - 08800101600169

rebless planar is a robotic-assisted upper extremity rehabilitation device that improves motor skills, range of moion, and strength, improving patients overall functional ability.
H ROBOTICS INC.
RPLSW
In Commercial Distribution

  • 08800101600169 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
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