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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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TITAN IMPLANTS, INC. - 00842448113962

3.3mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG12R1
In Commercial Distribution

  • 00842448113962 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113955

3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10S1
In Commercial Distribution

  • 00842448113955 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113948

3.3mm Diameter, 4.8mm Platform TG Implant Length 10mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG10R1
In Commercial Distribution

  • 00842448113948 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113931

3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8S1
In Commercial Distribution

  • 00842448113931 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448113924

3.3mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-3/4TG8R1
In Commercial Distribution

  • 00842448113924 ()


  • Dental implant system

Dexcom Stelo iOS Watch App - 00386270004659

No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom Stelo iOS Mobile App - 00386270004635

No Description
Dexcom, Inc.
SW14116
In Commercial Distribution

  • 00386270004635 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Stethee Pro Mobile iOS Application - 09351356000048

Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
M3DICINE PTY LTD
2.0.X
In Commercial Distribution

  • 09351356000048 ()


  • Phonocardiograph
  • Stethoscope application software

reSET-O® Mobile App, iOS - 10851580008118

reSET-O® Mobile Application running on iOS. 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

  • 10851580008118 ()


  • Mental health/function therapeutic software, screen-viewed

reSET® Mobile App, iOS - 10851580008088

reSET® Mobile Application running 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
In Commercial Distribution

  • 10851580008088 ()


  • Mental health/function therapeutic software, screen-viewed
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