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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All-Poly Tibial Implant, UC, Size H5, 11mm
MAXX ORTHOPEDICS, INC.
ATUCLH511-AK
In Commercial Distribution

  • 00840333921593 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 10mm
MAXX ORTHOPEDICS, INC.
ATUCLH510-AK
In Commercial Distribution

  • 00840333921586 ()


  • Uncoated knee tibia prosthesis, polyethylene
All-Poly Tibial Implant, UC, Size H5, 9mm
MAXX ORTHOPEDICS, INC.
ATUCLH509-AK
In Commercial Distribution

  • 00840333921579 ()


  • Uncoated knee tibia prosthesis, polyethylene
Periodontal Instrument, Scaler, Double Ended, HY-LITE Handle
A. TITAN INSTRUMENTS, INC.
H5 UL
In Commercial Distribution

  • 00841685107390 ()


  • Manual dental scaler, reusable
Perio Instrument, D-Lite Handle, Black
A. TITAN INSTRUMENTS, INC.
H5 DL
In Commercial Distribution

  • 00841685107383 ()


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

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
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
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
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