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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® 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

Esteem® Commander™ - 00812282020498

Esteem® Commander™ Model 6002
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020498 ()
906002-001

  • Fully-implantable middle ear implant system

Esteem® MedCem® - 00812282020276

MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020276 ()
901610-203

  • Fully-implantable middle ear implant system

Esteem® MedCem® - 00812282020252

MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020252 ()
901610-003

  • Fully-implantable middle ear implant system

Esteem® Sound Processor - 00812282020207

Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020207 ()
902001-002

  • Fully-implantable middle ear implant system

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

Freezor® Xtra - 00643169672482

CATHETER 227F5 FREEZOR XTRA5 LG 7F
MEDTRONIC, INC.
227F5
In Commercial Distribution

  • 00643169672482 ()

  • catheter curve 60mm
  • Catheter Gauge: 7.0 French
  • Length: 108.0 Centimeter
  • catheter tip length 6mm


  • Cardiac cryosurgical system catheter
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