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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INSERT TRAY FOR 90,000 RPM PEN F/MODULAR GRAPHIC CASE F/EPD
SYNTHES (U.S.A.) LP
690.594
In Commercial Distribution

  • H6796905940R ()
  • 10886982254917 ()
690594

  • Surgical instrument/implant rack
Pediatric EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396102
In Commercial Distribution

  • 20886333212426 ()
  • 00886333212422 ()

  • 75" x 125"
396102

  • Angiographic drape
Neonatal EPD Femoral Angio Drape 75" x 125" w/ Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396101
In Commercial Distribution

  • 20886333212419 ()
  • 00886333212415 ()

  • 75" x 125"
396101

  • Angiographic drape
Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396100
In Commercial Distribution

  • 20886333212402 ()
  • 00886333212408 ()

  • 75" x 125"
396100

  • Angiographic drape
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
FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding area, FOP NM 10 camera is been designed for true colour and monochrome imaging in visible spectrum of light and consists of an incoherent light source. Light from the device is shown into the patient eye & the camera of a smart phone is used to capture images of the eye.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
001
In Commercial Distribution

  • 08906096520014 ()


  • Ophthalmic fundus camera
  • Smartphone camera ophthalmic imaging lens
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