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 Class Implantable

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Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Regular IOS
Biodenta Swiss AG
CAD-SBOTS45
In Commercial Distribution

  • 07640169731419 ()
CAD-SBOTS45

  • Dental implant abutment analog, intraoral-scanning, single-use
Scan Body with Screw Compatible with Osstem (Hiossen) TSIII Mini IOS
Biodenta Swiss AG
CAD-SBOTS35
In Commercial Distribution

  • 07640169731402 ()
CAD-SBOTS35

  • Dental implant abutment analog, intraoral-scanning, single-use
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
Insertion Tool IOS Implant Replica Nobel Biocare N1™ NP/RP
Nobel Biocare AB
300966
In Commercial Distribution

  • 07332747162905 ()
300966

  • Dental implant suprastructure, temporary, preformed, reusable
Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DA-IOSDriver
In Commercial Distribution

  • 10841307128205 ()
DA-IOSDriver

  • Surgical screwdriver, reusable
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 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
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
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