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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TG OSSEOTITE® 5/6MM PILOT DRILL
BIOMET 3I, LLC
PSD500
In Commercial Distribution

  • 00844868014546 ()


  • Fixture/appliance dental drill bit, reusable
TG OSSEOTITE® 2/3MM PILOT DRILL
BIOMET 3I, LLC
PSD100
In Commercial Distribution

  • 00844868014539 ()


  • Fixture/appliance dental drill bit, reusable
No Description
Roche Diagnostics GmbH
08906556160
In Commercial Distribution

  • 07613336203569 ()
08906556160

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08991405190
In Commercial Distribution

  • 07613336171394 ()
08991405190

  • Thyroglobulin IVD, calibrator
No Description
Roche Diagnostics GmbH
08906564190
In Commercial Distribution

  • 07613336169582 ()
08906564190

  • Thyroglobulin IVD, kit, chemiluminescent immunoassay
RepairSet
Dentsply Implants Manufacturing GmbH
25-5020
In Commercial Distribution

  • 07392532223327 ()
25-5020

  • Dental/maxillofacial surgical procedure kit, non-medicated, single-use
Stand alone software used to collect, store and print patient data on various iOS devices
Zoll Medical Corporation
ZEPCRU
In Commercial Distribution

  • 00847946021924 ()


  • Medical equipment clinical data interfacing software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
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 Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
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