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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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Esteem® Personal Programmer - 00812282020078

Personal Programmer Model 8001
Envoy Medical Corporation
8001
In Commercial Distribution

  • 00812282020078 ()
908001-101

  • Fully-implantable middle ear implant system

Esteem® Sensor - 00812282020054

Sensor Model 7004, IS-1 Connector
Envoy Medical Corporation
7004
In Commercial Distribution

  • 00812282020054 ()
907004-003

  • Fully-implantable middle ear implant system

Esteem® Sensor - 00812282020047

Sensor Model 7004, IS-1 Connector
Envoy Medical Corporation
7004
In Commercial Distribution

  • 00812282020047 ()
907004-001

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020030

Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020023

Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020023 ()
907504-003

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020016

Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020016 ()
907504-001

  • Fully-implantable middle ear implant system

Esteem® Sensor - 00812282020009

Sensor Model 7010, IS-1 Connector
Envoy Medical Corporation
7010
In Commercial Distribution

  • 00812282020009 ()
907010-001

  • Fully-implantable middle ear implant system

BD Syringing Pipettes - 30382904913312

BD Syringing Pipettes (240)
BECTON, DICKINSON AND COMPANY
491331
In Commercial Distribution

  • 30382904913312 ()
  • 00382904913311 ()

  • Height: 16.9 Centimeter
  • Width: 26.3 Centimeter
  • Length: 46.5 Centimeter
491331

  • Pipette tip IVD

Cannula with Guide - 10840143901607

30cm Cannula with Guide
ATRICURE, INC.
CSK-6131
In Commercial Distribution

  • 10840143901607 ()
  • 30840143901670 ()
  • 50840143900110 ()

  • Length: 30 Centimeter
A001311

  • Cardiac radio-frequency ablation system generator

TactiSys™ - 07640157990316

Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
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