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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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Palatal Holder
Align Technology, Inc.
9032
In Commercial Distribution

  • 00816063021384 ()


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

  • 00816486021015 ()
18626

  • Voice synthesizer/digitizer
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
Not in Commercial Distribution

  • 00811050530399 ()
IMS

  • Infusion pump medication-dosage application software
ABBOTT PRISM Director Version 2.1
ABBOTT LABORATORIES
3R97-02
Not in Commercial Distribution

  • 00380740138400 ()
03R9702

  • Laboratory instrument/analyser application software IVD
ABBOTT PRISM Director Version 2.0
ABBOTT LABORATORIES
3R97-01
Not in Commercial Distribution

  • 00380740138394 ()
03R9701

  • Laboratory instrument/analyser application software IVD
Hearing Aid Feature watchOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095074 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature macOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195950095067 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature AirPods Pro 2 Firmware (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149931 ()


  • Air-conduction hearing aid, in-the-ear
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
Electrode Clip, Limb
NIHON KOHDEN AMERICA, INC.
NC-143E
In Commercial Distribution

  • 10841983103084 ()
  • 00841983103087 ()
NC-143E

  • Electrocardiograph, professional, multichannel
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