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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Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
reSET-O® Mobile Application running on Android. 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

  • 10851580008248 ()


  • 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
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
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-760T58
In Commercial Distribution

  • 08057432565388 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-760T55
In Commercial Distribution

  • 08057432565357 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-755T540
In Commercial Distribution

  • 08057432565333 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6080T56
In Commercial Distribution

  • 08057432565050 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6070T56
In Commercial Distribution

  • 08057432565036 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6100T55
In Commercial Distribution

  • 08057432565012 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6100T540
In Commercial Distribution

  • 08057432564930 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6095T540
In Commercial Distribution

  • 08057432564923 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6090T540
In Commercial Distribution

  • 08057432564916 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6085T540
In Commercial Distribution

  • 08057432564909 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6075T540
In Commercial Distribution

  • 08057432564886 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6070T540
In Commercial Distribution

  • 08057432564879 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-6065T540
In Commercial Distribution

  • 08057432564862 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-660T540
In Commercial Distribution

  • 08057432564855 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-655T540
In Commercial Distribution

  • 08057432564848 ()


  • Trans-facet-screw internal spinal fixation system, sterile
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#
SINTEA PLUSTEK SRL
PLS-645T540
In Commercial Distribution

  • 08057432564824 ()


  • Trans-facet-screw internal spinal fixation system, sterile
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