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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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AirStrip ONE Web Client - B15320030

Medical Device Software Application
Airstrip Technologies, Inc.
2003
In Commercial Distribution

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter

Bioness Integrated System (BITS)2.0.5 - 00815962020245

Bioness Integrated Therapy Software
BIONESS INC.
2.0.5
In Commercial Distribution

  • 00815962020245 ()


  • Perceptual-coordination assistive training device

CD TrueFit Software v5.3 - 07613389638875

CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software

StimRouter Clinician's Kit - 00815962020023

Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use

UbiqVue - B353UA2550MR1

Multi Patient Relay Software
Lifesignals, Inc.
UA2550-MR
In Commercial Distribution

  • B353UA2550MR1 ()


  • Physiological measuring device wireless data capture/transfer unit

UbiqVue - B353UA2251W1

Holter Web Server Software
Lifesignals, Inc.
UA2251-W
In Commercial Distribution

  • B353UA2251W1 ()


  • Network server

UbiqVue - B353UA2251S1

Holter Central Server Software
Lifesignals, Inc.
UA2251-S
In Commercial Distribution

  • B353UA2251S1 ()


  • Network server

Scopis - 07613327514179

ENT Software with TGS
Stryker Leibinger GmbH & Co. KG
8000-021-002
In Commercial Distribution

  • 07613327514179 ()
8000-021-002

  • Stereotactic system application software

SPINEMAP - 07613327359954

SPINEMAP¿ 3D 3.1 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-680-000
In Commercial Distribution

  • 07613327359954 ()
6002-680-000

  • Surgical planning/navigation-enhancement system

GEMS Mobile ECG - 00812324000297

GEMS Mobile ECG software
CardioComm Solutions, Inc
GM
In Commercial Distribution

  • 00812324000297 ()
GM

  • Electrocardiograph, home-use
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