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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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Instrument, Wrench Converter for W&H Hex Tools, Ø7.0mm
SOUTHERN IMPLANTS (PTY) LTD
I-WI-CST
In Commercial Distribution

  • 06009544014867 ()


  • Surgical torque wrench adaptor
Instrument, Wrench Converter for W&H Hex Tools, Ø8.0mm
SOUTHERN IMPLANTS (PTY) LTD
I-WI-CNB
In Commercial Distribution

  • 06009544014843 ()


  • Surgical torque wrench adaptor
LinkBio Instrument Trays (Mega C): Mega C Assembly Tools
Link Bio Corp
MCGAT
In Commercial Distribution

  • 00810022401583 ()


  • Instrument tray, reusable
Lock screw for direct MGUIDE insertion tools (pack 3)
MIS Implants Technologies Ltd.
CG-SCRW0
In Commercial Distribution

  • 07290109012070 ()
CG-SCRW0

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
ZAAG Reorder Kit for 4 Roots (Mini) (No Tools)
Zest Anchors, LLC
04030
In Commercial Distribution

  • 00840481109102 ()


  • Dental implant suprastructure, permanent, preformed
ZAAG Reorder Kit for 4 Roots (Standard) (No Tools)
Zest Anchors, LLC
04010
In Commercial Distribution

  • 00840481109089 ()


  • Dental implant suprastructure, permanent, preformed
MOUNT
BECTON, DICKINSON AND COMPANY
516750
In Commercial Distribution

  • 60382905167500 ()
  • 00382905167508 ()
516750

  • Intravenous injection automated detection/documentation system processor/transmitter
KIT GATEWAY
BECTON, DICKINSON AND COMPANY
516706
In Commercial Distribution

  • 60382905167067 ()
  • 00382905167065 ()
516706

  • Anaesthesia information system application software
KIT TABLET
BECTON, DICKINSON AND COMPANY
516704
In Commercial Distribution

  • 00382905167041 ()
516704

  • Intravenous injection automated detection/documentation system computer
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
EEG-1200A DESKTOP SYSTEM
NIHON KOHDEN AMERICA, INC.
EEG-1200A-DT
In Commercial Distribution

  • 00841983103995 ()
EEG-1200A-DT

  • Electroencephalograph
MEDICAL ISOLATION TRANSFORMER
NIHON KOHDEN AMERICA, INC.
A/ABC300-11MED
In Commercial Distribution

  • 00841983103988 ()
A/ABC300-11MED

  • Electroencephalograph
NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

  • Electroencephalograph
EEG REVIEW SUITE, 5 USER LICENSE
NIHON KOHDEN AMERICA, INC.
NK-REVSUITE-5
In Commercial Distribution

  • 00841983103926 ()
NK-REVSUITE-5

  • Electroencephalograph
LIVE VIEW PANEL SYSTEM
NIHON KOHDEN AMERICA, INC.
A/LVP
In Commercial Distribution

  • 00841983103858 ()
A/LVP

  • Electroencephalograph
EEG REVIEW SYSTEM
NIHON KOHDEN AMERICA, INC.
A/EEGR
In Commercial Distribution

  • 00841983103841 ()
A/EEGR

  • Electroencephalograph
256 CHANNEL AMPLIFIER for JE-120A
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983103834 ()
JE-120A-24

  • Neurophysiologic monitoring system
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