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 an iOS application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as an adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433019 ()


  • Mental health/function therapeutic software, screen-viewed
RESET Mobile Application runs on iOS and is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433002 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI5.000.05
Not in Commercial Distribution

  • ENTTUTG10MI5000051 ()

  • Diameter: Ø 5,0 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI5.000.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bottles with Trigger sprayer
ARGENTUM MEDICAL, LLC
4008TC
In Commercial Distribution

  • 10856040008424 ()
  • 00856040008427 ()


  • Antimicrobial wound irrigation solution
ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY.
ORGENTEC Diagnostika GmbH
ORG502
Not in Commercial Distribution

  • 04260157080010 ()
ORG502

  • Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
No Description
NT-Trading GmbH & Co. KG
UTG 10.MI3.342.05
Not in Commercial Distribution

  • ENTTUTG10MI3342051 ()

  • Diameter: Ø 3,3 - 4,25 mm gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG 10.MI3.342.05

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people who can not speak due to disability, injury or illness. High output speakers, durability and ingress protection for
TOBII DYNAVOX LLC
SC Tablet Mini
In Commercial Distribution

  • 07340074601929 ()
113527

  • Voice synthesizer/digitizer
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050002M
Not in Commercial Distribution

  • ENTTUTG2CON8050002M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 2,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050002M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
No Description
NT-Trading GmbH & Co. KG
UTG-2CON 8050001M
Not in Commercial Distribution

  • ENTTUTG2CON8050001M1 ()

  • 2-CONnect®-Abutment Ø 5,0 mm; gingiva height 0,5 mm; Compatible with implant system: Sweden & Martina Implantology™/ Premium TG® Implant
UTG-2CON 8050001M

  • Dental prosthesis/implant abutment screw
  • Dental implant suprastructure, permanent, preformed
VALIDATE THY2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analytes: Thyroglobulin (Tg).
Lgc Clinical Diagnostics, Inc.
908ro
In Commercial Distribution

  • 00850011135600 ()


  • Thyroglobulin IVD, control
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