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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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Sonova Brand (multiple brand) - 07613389402513

Easy Line Remote 2.0 app
Sonova AG
088-0012-70
In Commercial Distribution

  • 07613389402513 ()
088-0012-70

  • Audiometric/hearing device software

Unitron Brand - 07613389610918

Unitron Remote Plus 5.0 app
Sonova AG
088-5016
In Commercial Distribution

  • 07613389610918 ()
088-5016

  • Audiometric/hearing device software

Saltillo - 00816486021039

Classic TouchChat w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021039 ()
18626-1

  • Voice synthesizer/digitizer

Saltillo - 00816486021015

TouchChat HD w/ WordPower App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer

N/A - 00763000275655

SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000275655 ()


  • Multiple active implantable device programmer

CARDINAL HEALTH - 10195594880149

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL5
In Commercial Distribution

  • 50195594880147 ()
  • 10195594880149 ()
SBA11LLSL5

  • Laparoscopic surgical procedure kit, non-medicated, single-use

SMART TSF - 00885556746387

MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use

CARDINAL HEALTH - 10195594797133

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL4
In Commercial Distribution

  • 50195594797131 ()
  • 10195594797133 ()
SBA11LLSL4

  • Laparoscopic surgical procedure kit, non-medicated, single-use

SMART TSF - 00885556808016

MY TSF HOMECARE APP ANDROID
Smith & Nephew, Inc.
71075403
In Commercial Distribution

  • 00885556808016 ()
71075403

  • Wireless patient monitor/sensor reporting software, layperson-use

CARDINAL HEALTH - 10197106036471

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL6
In Commercial Distribution

  • 50197106036479 ()
  • 10197106036471 ()
SBA11LLSL6

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594959180

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLB
In Commercial Distribution

  • 50195594959188 ()
  • 10195594959180 ()
SBA11LLSLB

  • Laparoscopic surgical procedure kit, non-medicated, single-use

N/A - 00763000041618

SW APP A620 DBS PATIENT
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000041618 ()


  • Multiple active implantable device programmer

CARDINAL HEALTH - 10197106899885

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLF
In Commercial Distribution

  • 50197106899883 ()
  • 10197106899885 ()
SBA11LLSLF

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10197106767740

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLE
In Commercial Distribution

  • 50197106767748 ()
  • 10197106767740 ()
SBA11LLSLE

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Perifit - 07109615470598

Perifit Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
Not in Commercial Distribution

  • 07109615470598 ()


  • Pelvic floor muscle exerciser

CARDINAL HEALTH - 10197106436516

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSLD
In Commercial Distribution

  • 50197106436514 ()
  • 10197106436516 ()
SBA11LLSLD

  • Laparoscopic surgical procedure kit, non-medicated, single-use

N/A - 00763000520076

SW APP A710 SCS CLINICIAN
MEDTRONIC, INC.
A710
In Commercial Distribution

  • 00763000520076 ()


  • Multiple active implantable device programmer

CARDINAL HEALTH - 10195594700973

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL3
In Commercial Distribution

  • 50195594700971 ()
  • 10195594700973 ()
SBA11LLSL3

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10198956020597

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL8
In Commercial Distribution

  • 50198956020595 ()
  • 10198956020597 ()
SBA11LLSL8

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10198956001312

ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL7
In Commercial Distribution

  • 50198956001310 ()
  • 10198956001312 ()
SBA11LLSL7

  • Laparoscopic surgical procedure kit, non-medicated, single-use
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