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® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on Android. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008217 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed
TPH®3 flow Liquid Micro Hybrid Compula® Tip Introductory Kit
DENTSPLY INTERNATIONAL INC.
642715
Not in Commercial Distribution

  • D0026427151 ()

  • Total Volume: 0.125 Milliliter
  • 20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips
  • Weight: 0.25 Gram
642715

  • Dental composite resin
Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#
UNIFIED SPINE, LLC
502308
In Commercial Distribution

  • M9935023080 ()

  • Height: 8 Millimeter


  • Orthopaedic bone fixation plate spacer
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-20
In Commercial Distribution

  • 00841365116841 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-4
In Commercial Distribution

  • 00841365116292 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=290070#
BEST MEDICAL INTERNATIONAL, INC.
1192-15
In Commercial Distribution

  • 00841365114991 ()


  • General-purpose brachytherapy system applicator, remote-afterloading
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=305583#
BEST MEDICAL INTERNATIONAL, INC.
530-12
In Commercial Distribution

  • 00841365114328 ()


  • General-purpose brachytherapy system applicator, manual
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872#
INTERVENTIONAL SPINE, INC
6008
In Commercial Distribution

  • 00811954012694 ()
6008

  • Bone trephine, reusable
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