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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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myPhonak 4.0 app
Sonova AG
088-0013-08
In Commercial Distribution

  • 07613389402933 ()
088-0013-08

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-45
In Commercial Distribution

  • 07613389402926 ()
088-0013-45

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-15
In Commercial Distribution

  • 07613389402919 ()
088-0013-15

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013
In Commercial Distribution

  • 07613389402810 ()
088-0013

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-18
In Commercial Distribution

  • 07613389399301 ()
088-0013-18

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-70
In Commercial Distribution

  • 07613389399295 ()
088-0013-70

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-24
In Commercial Distribution

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-21
In Commercial Distribution

  • 07613389399271 ()
088-0013-21

  • Audiometric/hearing device software
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software
App on phone
EPIMINDER LIMITED
P00001
In Commercial Distribution

  • 00840336500009 ()
P00001

  • Electroencephalographic monitoring system
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
KIT, COMMON NO SPIRO
Cardinal Health 200, LLC
SP3692448E
In Commercial Distribution

  • 50888439347812 ()
  • 10888439347814 ()
SP3692448E

  • General surgical procedure kit, non-medicated, single-use
KIT, COMMON NO SPIRO
Cardinal Health 200, LLC
SP3692448G
In Commercial Distribution

  • 50888439632994 ()
  • 10888439632996 ()
SP3692448G

  • General surgical procedure kit, non-medicated, single-use
Common Ø4.8/ L=9
Megagen Implant Co. Ltd
MUAAL
In Commercial Distribution

  • 08809854027681 ()
MUAALT

  • Dental implant analog
Common Hex 0.9/ Long
Megagen Implant Co. Ltd
MHD090L
In Commercial Distribution

  • 08809854024277 ()
MHD090L

  • Surgical screwdriver, reusable
Common Ø7.95/ L=22
Megagen Implant Co. Ltd
DC6
In Commercial Distribution

  • 08809854020064 ()
DC6

  • Fixture/appliance dental drill bit, reusable
Common Ø8.4/ L=160
Megagen Implant Co. Ltd
DBH2
In Commercial Distribution

  • 08809854020057 ()
DBH2

  • Surgical screwdriver, reusable
Common Ø3.25/ L=30
Megagen Implant Co. Ltd
SR01
In Commercial Distribution

  • 08809854020040 ()
SR01

  • Surgical screwdriver, reusable
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