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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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ALBERS Grey Fade-Sun - 51 * 19 - 145 CAT 2
Fade To Grey Corp.
Albers-Grey Fade-Sun
In Commercial Distribution

  • G131ALBERSGF0S0 ()
  • 00810110310056 ()


  • Tinted non-prescription spectacles
ALBERS Chestnut Fade-Sun - 51 * 19 - 145 CAT 2
Fade To Grey Corp.
Albers-Chstnt Fd-Sun
In Commercial Distribution

  • G131ALBERSCHF0S0 ()
  • 00810110310032 ()


  • Tinted non-prescription spectacles
ALBERS Brown Horn-Sun - 51 * 19 - 145 CAT 2
Fade To Grey Corp.
Albers-Brown Hrn-Sun
In Commercial Distribution

  • G131ALBERSBNH0S0 ()
  • 00810110310018 ()


  • Tinted non-prescription spectacles
ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)
Lifewatch
MCT 1L Patch-Universal Gateway-Verizon
In Commercial Distribution

  • 00850725007040 ()


  • Electrocardiography telemetric monitoring system transmitter
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 Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008187 ()


  • 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 Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008156 ()


  • Mental health/function therapeutic software, screen-viewed
25ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5625
In Commercial Distribution

  • 20841305111442 ()
  • 10841305111438 ()
SE5625

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
23ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5623
In Commercial Distribution

  • 20841305111428 ()
  • 10841305111414 ()
SE5623

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
RESET-O is an Android application intended to increase retention of opioid use disorder patients in outpatient treatment by providing cognitive behavioral therapy as a adjunct to outpatient treatment.
Harvest Bio LLC
2.0.2
In Commercial Distribution

  • 00850074433026 ()


  • Mental health/function therapeutic software, screen-viewed
Disposable Dilators, Set of 4 Dilators (9-16 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator 1) 13-14 mm Dilator 1) 15-16 mm Dilator
BOSTON SCIENTIFIC CORPORATION
720117-01
In Commercial Distribution

  • 00878953005355 ()

  • 15 to 16 mm
  • 13 to 14 mm
  • 11 to 12 mm
  • 9 to 10 mm
720117-01

  • Corpus cavernosum dilator, single-use
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